Trial Outcomes & Findings for Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer (NCT NCT01116648)
NCT ID: NCT01116648
Last Updated: 2025-09-30
Results Overview
Was determined using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
155 participants
Primary outcome timeframe
At 28 days
Results posted on
2025-09-30
Participant Flow
Participant milestones
| Measure |
Dose Level 0 (20mg Ced+100mg Olap)
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Dose Level 1 (20mg Ced + 200mg Olap)
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Dose Level 2 (30mg Ced + 200mg Olap)
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Dose Level 3 (30mg Ced + 400mg Olap)
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Expansion Cohort at MTD
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Phase 2 - Olaparib Alone
Phase 2 - a total of 46 patients were randomized to receive olaparib alone.
|
Phase 2 - Cediranib/Olaparib
Phase 2 - a total of 44 patients were randomized to receive cediranib and olaparib.
|
Phase 1-T Dose Level 0-TA
Cediranib 30mg PO daily; Olaparib (tablet) 150mg PO BID
|
Phase 1-T Dose Level 1-TA
Cediranib 30mg PO daily; Olaparib (tablet) 200mg PO BID
|
Phase 1-T Dose Level 2-TA
Cediranib 30mg PO daily; Olaparib (tablet) 250mg PO BID
|
Phase 1-T Dose Level 0-TB
Cediranib 20mg PO daily; Olaparib (tablet) 200mg PO BID
|
Phase 1-T Dose Level 1-TB
Cediranib 20mg PO daily; Olaparib (tablet) 250 mg PO BID
|
Phase 1-T Dose Level 2-TB
Cediranib 20mg PO daily; Olaparib (tablet) 300mg PO BID
|
Phase 1-T PKOlap Expansion
Cediranib 30mg PO daily; Olaparib (tablet) 200mg BID; 7-day lead-in of single-agent olaparib
|
Phase 1-T PKCed Expansion
Cediranib 30mg PO daily; Olaparib (tablet) 200mg BID; 7-day lead-in of single agent cediranib
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Level 0
STARTED
|
3
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
|
|
Phase 1 Dose Level 0
COMPLETED
|
3
|
0
|
0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Dose Level 0
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
|
|
Phase 1 Dose Level 1
STARTED
|
0
|
3
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
|
Phase 1 Dose Level 1
COMPLETED
|
0
|
3
|
0
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0
|
0
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0
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0
|
0
|
0
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0
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0
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0
|
0
|
0
|
0
|
|
Phase 1 Dose Level 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Dose Level 2
STARTED
|
0
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0
|
7
|
0
|
0
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0
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0
|
0
|
0
|
0
|
0
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0
|
0
|
0
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0
|
|
Phase 1 Dose Level 2
COMPLETED
|
0
|
0
|
7
|
0
|
0
|
0
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0
|
0
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0
|
0
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0
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0
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0
|
0
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0
|
|
Phase 1 Dose Level 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
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0
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0
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0
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0
|
0
|
0
|
0
|
|
Phase 1 Dose Level 3
STARTED
|
0
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0
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0
|
6
|
0
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0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
|
Phase 1 Dose Level 3
COMPLETED
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
|
0
|
0
|
0
|
|
Phase 1 Dose Level 3
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
0
|
|
Expansion at Maximum Tolerated Dose
STARTED
|
0
|
0
|
0
|
0
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Expansion at Maximum Tolerated Dose
COMPLETED
|
0
|
0
|
0
|
0
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Expansion at Maximum Tolerated Dose
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
46
|
44
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
0
|
|
Phase 2
COMPLETED
|
0
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0
|
0
|
0
|
0
|
46
|
44
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
|
0
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0
|
0
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0
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0
|
0
|
0
|
|
Phase 1-T Dose Level 0-TA
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1-T Dose Level 0-TA
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1-T Dose Level 0-TA
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
0
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0
|
0
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0
|
0
|
0
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|
Phase 1-T Dose Level 1-TA
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
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0
|
|
Phase 1-T Dose Level 1-TA
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1-T Dose Level 1-TA
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1-T Dose Level 2-TA
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1-T Dose Level 2-TA
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
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0
|
3
|
0
|
0
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0
|
0
|
0
|
|
Phase 1-T Dose Level 2-TA
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
0
|
|
Phase 1-T Dose Level 0-TB
STARTED
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Phase 1-T Dose Level 0-TB
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Phase 1-T Dose Level 0-TB
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1-T Dose Level 1-TB
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Phase 1-T Dose Level 1-TB
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Phase 1-T Dose Level 1-TB
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1-T Dose Level 2-TB
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
|
Phase 1-T Dose Level 2-TB
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
|
Phase 1-T Dose Level 2-TB
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1-T PKOlap Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
|
Phase 1-T PKOlap Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
|
Phase 1-T PKOlap Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1-T PKCed Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
|
Phase 1-T PKCed Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
|
Phase 1-T PKCed Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 0 (20mg Ced+100mg Olap)
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Dose Level 1 (20mg Ced + 200mg Olap)
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Dose Level 2 (30mg Ced + 200mg Olap)
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Dose Level 3 (30mg Ced + 400mg Olap)
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Expansion Cohort at MTD
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Phase 2 - Olaparib Alone
Phase 2 - a total of 46 patients were randomized to receive olaparib alone.
|
Phase 2 - Cediranib/Olaparib
Phase 2 - a total of 44 patients were randomized to receive cediranib and olaparib.
|
Phase 1-T Dose Level 0-TA
Cediranib 30mg PO daily; Olaparib (tablet) 150mg PO BID
|
Phase 1-T Dose Level 1-TA
Cediranib 30mg PO daily; Olaparib (tablet) 200mg PO BID
|
Phase 1-T Dose Level 2-TA
Cediranib 30mg PO daily; Olaparib (tablet) 250mg PO BID
|
Phase 1-T Dose Level 0-TB
Cediranib 20mg PO daily; Olaparib (tablet) 200mg PO BID
|
Phase 1-T Dose Level 1-TB
Cediranib 20mg PO daily; Olaparib (tablet) 250 mg PO BID
|
Phase 1-T Dose Level 2-TB
Cediranib 20mg PO daily; Olaparib (tablet) 300mg PO BID
|
Phase 1-T PKOlap Expansion
Cediranib 30mg PO daily; Olaparib (tablet) 200mg BID; 7-day lead-in of single-agent olaparib
|
Phase 1-T PKCed Expansion
Cediranib 30mg PO daily; Olaparib (tablet) 200mg BID; 7-day lead-in of single agent cediranib
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Level 3
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Participants were assessed according to diagnosis.
Baseline characteristics by cohort
| Measure |
Phase 1 Dose Level 0 (3 Participants)
n=3 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
This was an open-label, phase 1, dose-escalation trial performed at two participating institutions evaluating increasing doses of once daily cediranib and twice daily olaparib administered continuously in 28-day cycles. Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules. The primary objectives were to determine the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of this combination. Secondary objectives included assessment of treatment-related toxicities and preliminary assessment of clinical activity as measured by response rate, clinical benefit rate (CBR) and progression-free survival (PFS), defined as time from initiation of therapy to disease progression or death from any cause.
|
Phase 1 Dose Level 1 (3 Participants)
n=3 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
This was an open-label, phase 1, dose-escalation trial performed at two participating institutions evaluating increasing doses of once daily cediranib and twice daily olaparib administered continuously in 28-day cycles. Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules. The primary objectives were to determine the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of this combination. Secondary objectives included assessment of treatment-related toxicities and preliminary assessment of clinical activity as measured by response rate, clinical benefit rate (CBR) and progression-free survival (PFS), defined as time from initiation of therapy to disease progression or death from any cause.
|
Phase 1 Dose Level 2 (7 Participants)
n=7 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
This was an open-label, phase 1, dose-escalation trial performed at two participating institutions evaluating increasing doses of once daily cediranib and twice daily olaparib administered continuously in 28-day cycles. Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules. The primary objectives were to determine the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of this combination. Secondary objectives included assessment of treatment-related toxicities and preliminary assessment of clinical activity as measured by response rate, clinical benefit rate (CBR) and progression-free survival (PFS), defined as time from initiation of therapy to disease progression or death from any cause.
|
Phase 1 Dose Level 3 (6 Participants)
n=6 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
This was an open-label, phase 1, dose-escalation trial performed at two participating institutions evaluating increasing doses of once daily cediranib and twice daily olaparib administered continuously in 28-day cycles. Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules. The primary objectives were to determine the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of this combination. Secondary objectives included assessment of treatment-related toxicities and preliminary assessment of clinical activity as measured by response rate, clinical benefit rate (CBR) and progression-free survival (PFS), defined as time from initiation of therapy to disease progression or death from any cause.
|
Phase 1 Expansion at MTD (9 Participants)
n=9 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
This was an open-label, phase 1, dose-escalation trial performed at two participating institutions evaluating increasing doses of once daily cediranib and twice daily olaparib administered continuously in 28-day cycles. Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules. The primary objectives were to determine the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of this combination. Secondary objectives included assessment of treatment-related toxicities and preliminary assessment of clinical activity as measured by response rate, clinical benefit rate (CBR) and progression-free survival (PFS), defined as time from initiation of therapy to disease progression or death from any cause.
|
Phase 2 - Olaparib Alone
n=46 Participants
Assess the efficacy (as measured by progression-free survival (PFS) ) of olaparib alone in recurrent grade 2 or 3 platinum-sensitive papillary-serous or endometrioid ovarian, fallopian tube, or peritoneal cancer.
|
Phase 2 - Cediranib/Olaparib
n=44 Participants
Assess the efficacy (as measured by progression-free survival (PFS) ) of the combination of cediranib and olaparib in recurrent grade 2 or 3 platinum-sensitive papillary-serous or endometrioid ovarian, fallopian tube, or peritoneal cancer.
|
Phase 1-T Dose Level 0-TA
n=3 Participants
Cediranib 30mg PO daily; Olaparib (tablet) 150mg PO BID
|
Phase 1-T Dose Level 1-TA
n=6 Participants
Cediranib 30mg PO daily; Olaparib (tablet) 200mg PO BID
|
Phase 1-T Dose Level 2-TA
n=3 Participants
Cediranib 30mg PO daily; Olaparib (tablet) 250mgPO BID
|
Phase 1-T Dose Level 0-TB
n=3 Participants
Cediranib 20mg PO daily; Olaparib (tablet) 200mg PO BID
|
Phase 1-T Dose Level 1-TB
n=3 Participants
Cediranib 20mg PO daily; Olaparib (tablet) 250mg PO BID
|
Phase 1-T Dose Level 2-TB
n=6 Participants
Cediranib 20mg PO daily; Olaparib (tablet) 300mg PO BID
|
Phase 1-T PKOlap Expansion
n=6 Participants
Cediranib 30mg PO daily; Olaparib (tablet) 200mg PO BID; 7-day lead-in of single-agent olaparib
|
Phase 1-T PKCed Expansion
n=7 Participants
Cediranib 30mg PO daily; Olaparib (tablet) 200mg PO BID; 7-day lead-in of single-agent cediranib
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49 years
n=3 Participants
|
59 years
n=3 Participants
|
57 years
n=7 Participants
|
56 years
n=6 Participants
|
57 years
n=9 Participants
|
58.1 years
n=46 Participants
|
57.8 years
n=44 Participants
|
55.6 years
n=3 Participants
|
61.5 years
n=6 Participants
|
58.7 years
n=3 Participants
|
57.8 years
n=3 Participants
|
59.0 years
n=3 Participants
|
59.8 years
n=6 Participants
|
58.7 years
n=6 Participants
|
54.5 years
n=7 Participants
|
57.7 years
n=155 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
46 Participants
n=46 Participants
|
44 Participants
n=44 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
155 Participants
n=155 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=155 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=155 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
44 Participants
n=46 Participants
|
43 Participants
n=44 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
149 Participants
n=155 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=46 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=155 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=155 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=155 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=155 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=46 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=155 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
42 Participants
n=46 Participants
|
43 Participants
n=44 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
141 Participants
n=155 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=155 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=155 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
7 participants
n=7 Participants
|
6 participants
n=6 Participants
|
9 participants
n=9 Participants
|
46 participants
n=46 Participants
|
44 participants
n=44 Participants
|
3 participants
n=3 Participants
|
6 participants
n=6 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
7 participants
n=7 Participants
|
155 participants
n=155 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
34 Participants
n=46 Participants
|
31 Participants
n=44 Participants
|
2 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
105 Participants
n=155 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
1 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
12 Participants
n=46 Participants
|
13 Participants
n=44 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
50 Participants
n=155 Participants
|
|
Diagnosis
Ovarian
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
46 Participants
n=46 Participants
|
44 Participants
n=44 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
147 Participants
n=155 Participants
|
|
Diagnosis
Breast
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=155 Participants
|
|
BRCA Status
Mutation carrier
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
24 Participants
n=46 Participants
|
23 Participants
n=44 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
75 Participants
n=155 Participants
|
|
BRCA Status
Wild-type
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
11 Participants
n=46 Participants
|
12 Participants
n=44 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
48 Participants
n=155 Participants
|
|
BRCA Status
Unknown
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
11 Participants
n=46 Participants
|
9 Participants
n=44 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
32 Participants
n=155 Participants
|
|
Number of prior regimens (median; Phase 1)
Ovarian
|
3.5 number of prior regimens
n=2 Participants • Participants were assessed according to diagnosis.
|
6.5 number of prior regimens
n=2 Participants • Participants were assessed according to diagnosis.
|
2 number of prior regimens
n=5 Participants • Participants were assessed according to diagnosis.
|
2 number of prior regimens
n=4 Participants • Participants were assessed according to diagnosis.
|
1 number of prior regimens
n=7 Participants • Participants were assessed according to diagnosis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 number of prior regimens
n=20 Participants • Participants were assessed according to diagnosis.
|
|
Number of prior regimens (median; Phase 1)
Breast
|
3 number of prior regimens
n=1 Participants • Participants were assessed according to diagnosis.
|
3 number of prior regimens
n=1 Participants • Participants were assessed according to diagnosis.
|
5 number of prior regimens
n=2 Participants • Participants were assessed according to diagnosis.
|
2 number of prior regimens
n=2 Participants • Participants were assessed according to diagnosis.
|
2.5 number of prior regimens
n=2 Participants • Participants were assessed according to diagnosis.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3 number of prior regimens
n=8 Participants • Participants were assessed according to diagnosis.
|
|
Number of Prior Lines (Phase 2 and 1-T)
1
|
—
|
—
|
—
|
—
|
—
|
17 Participants
n=46 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
26 Participants
n=44 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
1 Participants
n=3 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
3 Participants
n=6 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
1 Participants
n=3 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
1 Participants
n=3 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
0 Participants
n=3 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
2 Participants
n=6 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
2 Participants
n=6 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
2 Participants
n=7 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
55 Participants
n=127 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
|
Number of Prior Lines (Phase 2 and 1-T)
2
|
—
|
—
|
—
|
—
|
—
|
18 Participants
n=46 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
10 Participants
n=44 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
1 Participants
n=3 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
1 Participants
n=6 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
1 Participants
n=3 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
0 Participants
n=3 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
0 Participants
n=3 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
3 Participants
n=6 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
1 Participants
n=6 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
5 Participants
n=7 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
40 Participants
n=127 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
|
Number of Prior Lines (Phase 2 and 1-T)
3 or More
|
—
|
—
|
—
|
—
|
—
|
11 Participants
n=46 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
8 Participants
n=44 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
1 Participants
n=3 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
2 Participants
n=6 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
1 Participants
n=3 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
2 Participants
n=3 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
3 Participants
n=3 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
1 Participants
n=6 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
3 Participants
n=6 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
0 Participants
n=7 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
32 Participants
n=127 Participants • Number of Prior Lines was captured as displayed for Phase 2 and Phase 1-T cohorts.
|
|
Platinum-sensitivity (ovarian patients only)
Platinum-sensitive
|
0 Participants
n=2 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
2 Participants
n=2 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
4 Participants
n=5 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
4 Participants
n=4 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
4 Participants
n=7 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
46 Participants
n=46 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
44 Participants
n=44 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
0 Participants
n=3 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
3 Participants
n=6 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
2 Participants
n=3 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
1 Participants
n=3 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
1 Participants
n=3 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
2 Participants
n=6 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
2 Participants
n=6 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
4 Participants
n=7 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
119 Participants
n=147 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
|
Platinum-sensitivity (ovarian patients only)
Platinum-resistant
|
2 Participants
n=2 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
0 Participants
n=2 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
1 Participants
n=5 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
0 Participants
n=4 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
3 Participants
n=7 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
0 Participants
n=46 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
0 Participants
n=44 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
3 Participants
n=3 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
3 Participants
n=6 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
1 Participants
n=3 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
2 Participants
n=3 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
2 Participants
n=3 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
4 Participants
n=6 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
4 Participants
n=6 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
3 Participants
n=7 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
28 Participants
n=147 Participants • Platinum-sensitivity is reported only for the Ovarian cohort
|
|
Histology (ovarian patients only; Phase 1 and Phase 2)
Papillary-serous
|
2 Participants
n=2 Participants • Histologic subtype only applies to the Ovarian cohort
|
2 Participants
n=2 Participants • Histologic subtype only applies to the Ovarian cohort
|
3 Participants
n=5 Participants • Histologic subtype only applies to the Ovarian cohort
|
3 Participants
n=4 Participants • Histologic subtype only applies to the Ovarian cohort
|
6 Participants
n=7 Participants • Histologic subtype only applies to the Ovarian cohort
|
40 Participants
n=46 Participants • Histologic subtype only applies to the Ovarian cohort
|
41 Participants
n=44 Participants • Histologic subtype only applies to the Ovarian cohort
|
2 Participants
n=3 Participants • Histologic subtype only applies to the Ovarian cohort
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
99 Participants
n=113 Participants • Histologic subtype only applies to the Ovarian cohort
|
|
Histology (ovarian patients only; Phase 1 and Phase 2)
Endometrioid
|
0 Participants
n=2 Participants • Histologic subtype only applies to the Ovarian cohort
|
0 Participants
n=2 Participants • Histologic subtype only applies to the Ovarian cohort
|
0 Participants
n=5 Participants • Histologic subtype only applies to the Ovarian cohort
|
0 Participants
n=4 Participants • Histologic subtype only applies to the Ovarian cohort
|
1 Participants
n=7 Participants • Histologic subtype only applies to the Ovarian cohort
|
5 Participants
n=46 Participants • Histologic subtype only applies to the Ovarian cohort
|
0 Participants
n=44 Participants • Histologic subtype only applies to the Ovarian cohort
|
0 Participants
n=3 Participants • Histologic subtype only applies to the Ovarian cohort
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6 Participants
n=113 Participants • Histologic subtype only applies to the Ovarian cohort
|
|
Histology (ovarian patients only; Phase 1 and Phase 2)
Mixed
|
0 Participants
n=2 Participants • Histologic subtype only applies to the Ovarian cohort
|
0 Participants
n=2 Participants • Histologic subtype only applies to the Ovarian cohort
|
1 Participants
n=5 Participants • Histologic subtype only applies to the Ovarian cohort
|
1 Participants
n=4 Participants • Histologic subtype only applies to the Ovarian cohort
|
0 Participants
n=7 Participants • Histologic subtype only applies to the Ovarian cohort
|
0 Participants
n=46 Participants • Histologic subtype only applies to the Ovarian cohort
|
2 Participants
n=44 Participants • Histologic subtype only applies to the Ovarian cohort
|
0 Participants
n=3 Participants • Histologic subtype only applies to the Ovarian cohort
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
n=113 Participants • Histologic subtype only applies to the Ovarian cohort
|
|
Histology (ovarian patients only; Phase 1 and Phase 2)
Other
|
0 Participants
n=2 Participants • Histologic subtype only applies to the Ovarian cohort
|
0 Participants
n=2 Participants • Histologic subtype only applies to the Ovarian cohort
|
1 Participants
n=5 Participants • Histologic subtype only applies to the Ovarian cohort
|
0 Participants
n=4 Participants • Histologic subtype only applies to the Ovarian cohort
|
0 Participants
n=7 Participants • Histologic subtype only applies to the Ovarian cohort
|
1 Participants
n=46 Participants • Histologic subtype only applies to the Ovarian cohort
|
1 Participants
n=44 Participants • Histologic subtype only applies to the Ovarian cohort
|
1 Participants
n=3 Participants • Histologic subtype only applies to the Ovarian cohort
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
n=113 Participants • Histologic subtype only applies to the Ovarian cohort
|
|
Histology (Phase 1-T)
Serous
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
5 Participants
n=6 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
2 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
3 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
2 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
4 Participants
n=6 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
4 Participants
n=6 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
6 Participants
n=7 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
28 Participants
n=37 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
|
Histology (Phase 1-T)
Endometrioid
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=6 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
1 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=6 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
1 Participants
n=6 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=7 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
2 Participants
n=37 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
|
Histology (Phase 1-T)
Clear Cell
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
1 Participants
n=6 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
1 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
1 Participants
n=6 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=6 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=7 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
3 Participants
n=37 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
|
Histology (Phase 1-T)
Other/Unknown
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=6 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
0 Participants
n=3 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
1 Participants
n=6 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
1 Participants
n=6 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
1 Participants
n=7 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
4 Participants
n=37 Participants • Histologic sub-types were captured/displayed differently between phases in this trial. The histologic subtypes in this table refer to those captured/displayed for Phase 1-T participants.
|
PRIMARY outcome
Timeframe: At 28 daysWas determined using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Outcome measures
| Measure |
Level 0
n=3 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Level 1
n=3 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Level 2
n=7 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Level 3
n=6 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: At 28 DaysThis trial employed a 3+3 design, escalating on 0/3 or 1/6 DLT, and de-escalating if 2 DLTs were encountered. The MTD (maximum tolerated dose) was the dose at which no more than 1 patient developed a dose-limiting toxicity (DLT) when at least 6 patients had been treated.
Outcome measures
| Measure |
Level 0
n=28 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Level 1
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Level 2
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Level 3
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
|---|---|---|---|---|
|
The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I)
Cediranib PO daily
|
30 mg
|
—
|
—
|
—
|
|
The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I)
Olaparib PO BID
|
200 mg
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Time from start of treatment to time of objective disease progression, assessed up to 5 yearsPopulation: Platinum-sensitive recurrent grade 2 or 3 platinum-sensitive papillary-serous or endometrioid ovarian, fallopian tube, or peritoneal cancer.
Evaluated by Kaplan-Meier analysis and log-rank test for between group comparison, and median survival times reported. PFS is defined as time from randomization to investigator-assessed radiographic progression by RECIST 1.1 criteria or death. Patients alive without evidence of progression were censored at the last disease assessment.
Outcome measures
| Measure |
Level 0
n=46 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Level 1
n=44 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Level 2
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Level 3
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II)
|
8.2 months
Interval 1.0 to 49.0
|
16.5 months
Interval 4.0 to 60.0
|
—
|
—
|
PRIMARY outcome
Timeframe: At 28 daysThe Phase 1-T component of this trial employed a 3+3 design, escalating on 0/3 or 1/6 DLT, and de-escalating if 2 DLTs were encountered. The MTD (maximum tolerated dose) was the dose at which no more than 1 patient developed a DLT when at least 6 patients had been treated.
Outcome measures
| Measure |
Level 0
n=37 Participants
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Level 1
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Level 2
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
Level 3
Assess the maximum tolerated dose (MTD) of cediranib in combination with olaparib in the treatment of recurrent ovarian, fallopian tube, or peritoneal cancer or metastatic triple-negative breast cancer.
|
|---|---|---|---|---|
|
The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T).
Cediranib PO daily
|
30 mg
|
—
|
—
|
—
|
|
The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T).
Olaparib (tablet) PO BID
|
200 mg
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Adverse Events monitored for 3 years, mortality assessed up to 5 yearsWill be determined using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, study-related adverse events observed in \>10% of participants (n=28).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsThe response rates are compared by an exact test and 95% confidence intervals will also be reported. Objective response rate (ORR) is defined as the best confirmed RECIST response, ORR is defined as the number of participants with CR, PR or SD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsWill be evaluated by Kaplan-Meier analysis and log-rank test for between-group comparison, and median survival time will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsWill be determined using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. This outcome reports treatment-related adverse events that occurred in at least 10% of participants.
Outcome measures
Outcome data not reported
Adverse Events
Phase I Dose Level 0
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase I Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase I Dose Level 2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 6 deaths
Phase I Dose Level 3
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase I Expansion Cohort at MTD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 7 deaths
Phase II Olaparib Alone
Serious events: 2 serious events
Other events: 45 other events
Deaths: 29 deaths
Phase II Cediranib/Olaparib
Serious events: 3 serious events
Other events: 44 other events
Deaths: 26 deaths
Phase I-T Dose Level 0-TA
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I-T Dose Level 1-TA
Serious events: 0 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase I-T Dose Level 1-TPKCed
Serious events: 1 serious events
Other events: 7 other events
Deaths: 2 deaths
Phase I-T Dose Level 1-TPKOlap
Serious events: 0 serious events
Other events: 6 other events
Deaths: 3 deaths
Phase I-T Dose Level 2-TA
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I-T Dose Level 0-TB
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I-T Dose Level 1-TB
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase I-T Dose Level 2-TB
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase I Dose Level 0
n=3 participants at risk
Participants received cediranib 20 mg daily and olaparib 100 mg twice daily.
Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules.
|
Phase I Dose Level 1
n=3 participants at risk
Participants received cediranib 20 mg daily and olaparib 200 mg twice daily.
Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules.
|
Phase I Dose Level 2
n=7 participants at risk
Participants received cediranib 30 mg daily and olaparib 200 mg twice daily.
Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules.
|
Phase I Dose Level 3
n=6 participants at risk
Participants received cediranib 30 mg daily and olaparib 400 mg twice daily.
Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules.
|
Phase I Expansion Cohort at MTD
n=9 participants at risk
Participants received cediranib 30 mg daily and olaparib 200 mg twice daily.
Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules.
|
Phase II Olaparib Alone
n=46 participants at risk
Participants received olaparib capsule monotherapy 400 mg orally twice daily.
|
Phase II Cediranib/Olaparib
n=44 participants at risk
Participants received a previously established recommended Phase 2 dose of cediranib 30 mg orally daily with olaparib capsules 200 mg orally twice daily.
|
Phase I-T Dose Level 0-TA
n=3 participants at risk
Participants received 30 mg cediranib daily with olaparib tablets at 150 mg twice daily.
|
Phase I-T Dose Level 1-TA
n=6 participants at risk
Participants received 30 mg cediranib daily with olaparib tablets at 200 mg twice daily.
|
Phase I-T Dose Level 1-TPKCed
n=7 participants at risk
Participants received 30 mg cediranib daily with olaparib tablets at 200 mg twice daily.
|
Phase I-T Dose Level 1-TPKOlap
n=6 participants at risk
Participants received 30 mg cediranib daily with olaparib tablets at 200 mg twice daily.
|
Phase I-T Dose Level 2-TA
n=3 participants at risk
Participants received 30 mg cediranib daily with olaparib tablets at 250 mg twice daily.
|
Phase I-T Dose Level 0-TB
n=3 participants at risk
Participants received 20 mg cediranib daily with olaparib tablets at 200 mg twice daily.
|
Phase I-T Dose Level 1-TB
n=3 participants at risk
Participants received 20 mg cediranib daily with olaparib tablets at 250 mg twice daily.
|
Phase I-T Dose Level 2-TB
n=6 participants at risk
Participants received 20 mg cediranib daily with olaparib tablets at 300 mg twice daily.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
4.5%
2/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
2.2%
1/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
2.3%
1/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Serum amylase increased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
2.2%
1/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
2.2%
1/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
Other adverse events
| Measure |
Phase I Dose Level 0
n=3 participants at risk
Participants received cediranib 20 mg daily and olaparib 100 mg twice daily.
Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules.
|
Phase I Dose Level 1
n=3 participants at risk
Participants received cediranib 20 mg daily and olaparib 200 mg twice daily.
Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules.
|
Phase I Dose Level 2
n=7 participants at risk
Participants received cediranib 30 mg daily and olaparib 200 mg twice daily.
Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules.
|
Phase I Dose Level 3
n=6 participants at risk
Participants received cediranib 30 mg daily and olaparib 400 mg twice daily.
Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules.
|
Phase I Expansion Cohort at MTD
n=9 participants at risk
Participants received cediranib 30 mg daily and olaparib 200 mg twice daily.
Cediranib was administered as 10 and 15 mg tablets and olaparib as 50 mg capsules.
|
Phase II Olaparib Alone
n=46 participants at risk
Participants received olaparib capsule monotherapy 400 mg orally twice daily.
|
Phase II Cediranib/Olaparib
n=44 participants at risk
Participants received a previously established recommended Phase 2 dose of cediranib 30 mg orally daily with olaparib capsules 200 mg orally twice daily.
|
Phase I-T Dose Level 0-TA
n=3 participants at risk
Participants received 30 mg cediranib daily with olaparib tablets at 150 mg twice daily.
|
Phase I-T Dose Level 1-TA
n=6 participants at risk
Participants received 30 mg cediranib daily with olaparib tablets at 200 mg twice daily.
|
Phase I-T Dose Level 1-TPKCed
n=7 participants at risk
Participants received 30 mg cediranib daily with olaparib tablets at 200 mg twice daily.
|
Phase I-T Dose Level 1-TPKOlap
n=6 participants at risk
Participants received 30 mg cediranib daily with olaparib tablets at 200 mg twice daily.
|
Phase I-T Dose Level 2-TA
n=3 participants at risk
Participants received 30 mg cediranib daily with olaparib tablets at 250 mg twice daily.
|
Phase I-T Dose Level 0-TB
n=3 participants at risk
Participants received 20 mg cediranib daily with olaparib tablets at 200 mg twice daily.
|
Phase I-T Dose Level 1-TB
n=3 participants at risk
Participants received 20 mg cediranib daily with olaparib tablets at 250 mg twice daily.
|
Phase I-T Dose Level 2-TB
n=6 participants at risk
Participants received 20 mg cediranib daily with olaparib tablets at 300 mg twice daily.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
18.2%
8/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.4%
5/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
4/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
42.9%
3/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
44.4%
4/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
32.6%
15/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
45.5%
20/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
42.9%
3/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
4/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
8.7%
4/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.6%
6/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
57.1%
4/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
3/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.0%
6/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
31.8%
14/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.0%
6/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
25.0%
11/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
15.9%
7/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
15.9%
7/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
10.9%
5/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
15.9%
7/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
42.9%
3/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
18.2%
8/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Cardiac disorders
Cardiac disorders - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
9.1%
4/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Cholesterol high
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.4%
5/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
71.4%
5/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
32.6%
15/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
40.9%
18/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
25.0%
11/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.6%
6/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.6%
6/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
85.7%
6/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
83.3%
5/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
9/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
30.4%
14/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
93.2%
41/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
6/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
71.4%
5/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
83.3%
5/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
83.3%
5/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.0%
6/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.7%
10/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.6%
6/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
10.9%
5/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.6%
6/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
21.7%
10/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
25.0%
11/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
25.0%
11/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.0%
6/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
20.5%
9/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
15.9%
7/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Eye disorders
Eye disorders - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
General disorders
Fatigue
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
85.7%
6/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
6/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
9/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
78.3%
36/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
90.9%
40/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
6/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
71.4%
5/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
6/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
6/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Eye disorders
Floaters
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
9.1%
4/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, NOS
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
18.2%
8/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
General disorders
General disorders and administration site conditions - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Infections and infestations
Gum infection
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
42.9%
3/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
44.4%
4/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
19.6%
9/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
54.5%
24/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
42.9%
3/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Hemoglobin increased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
9.1%
4/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
27.3%
12/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Vascular disorders
Hot flashes
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
8.7%
4/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
9.1%
4/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
4/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
3/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
18.2%
8/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
9.1%
4/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.4%
5/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
9.1%
4/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
18.2%
8/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
23.9%
11/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.7%
10/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
42.9%
3/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
4/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
25.0%
11/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
57.1%
4/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.4%
5/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
3/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
18.2%
8/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
INR increased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
18.2%
8/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Investigations - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
8.7%
4/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.4%
5/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
20.5%
9/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.4%
5/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
3/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
15.9%
7/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
9.1%
4/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
57.1%
4/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
4/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
77.8%
7/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
78.3%
36/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
79.5%
35/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
83.3%
5/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
57.1%
4/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
83.3%
5/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
83.3%
5/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Nervous system disorders - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
42.9%
3/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
9.1%
4/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
3/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
15.2%
7/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
18.2%
8/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
44.4%
4/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.0%
6/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
25.0%
11/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
18.2%
8/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Reproductive system and breast disorders
Pelvic floor muscle weakness
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.4%
5/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
3/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
23.9%
11/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
36.4%
16/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
83.3%
5/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
42.9%
3/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.4%
5/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.4%
5/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
42.9%
3/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
8.7%
4/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.5%
3/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
6.8%
3/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
8.7%
4/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
9.1%
4/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
42.9%
3/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
8.7%
4/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
9.1%
4/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
2/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.0%
6/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
20.5%
9/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
10.9%
5/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.6%
6/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
4/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Vascular disorders
Vascular disorders - Other, NOS
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
3/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
30.4%
14/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
25.0%
11/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
100.0%
3/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
50.0%
3/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
42.9%
3/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
66.7%
4/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Weight gain
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
14.3%
1/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
11.1%
1/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
27.3%
12/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
28.6%
2/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
2/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
22.2%
2/9 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
13.0%
6/46 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
15.9%
7/44 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/7 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
0.00%
0/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
33.3%
1/3 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
16.7%
1/6 • Adverse Events monitored for 3 years, mortality assessed up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60