Trial Outcomes & Findings for A Safety Study in Participants With Advanced Solid Tumors (NCT NCT01284335)
NCT ID: NCT01284335
Last Updated: 2019-01-10
Results Overview
A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade 4 neutropenia lasting more than 5 days. Grade 4 neutropenia with fever or Grade 4 thrombocytopenia, regardless of duration; Grade ≥3 thrombocytopenia with bleeding, regardless of duration; Grade ≥3 nonhematologic toxicity (excluding nausea/vomiting or diarrhea that can be controlled with medication, and alopecia). Grade 3 electrolyte toxicity (for example, hypokalemia, hypophosphatemia) will not be considered a DLT unless it is considered related to the study drug or combination and does not resolve with standard replacement treatments within 42 days after Cycle 1 Day 1. A summary of other nonserious AEs and all Serious Adverse Events (SAE), regardless of causality is located in the Reported Adverse Event section.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
234 participants
Primary outcome timeframe
Baseline to Cycle 1 (Up to Day 28)
Results posted on
2019-01-10
Participant Flow
Study completion was defined as when the recommended dose of LY573636 (tasisulam) was defined for each treatment arm or if a decision was made to stop enrollment in the study for business reasons.
Participant milestones
| Measure |
Arm A Tasisulam + Gemcitabine Dose Escalation
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Confirmation
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B* Tasisulam + Docetaxel Dose Escalation
Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B1 Tasisulam + Docetaxel Dose Escalation
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm C Tasisulam + Temozolomide Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm C Tasisulam + Temozolomide Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D* Tasisulam + Cisplatin Dose Escalation
Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
|
Arm D Tasisulam + Cisplatin Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D Tasisulam + Cisplatin Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
33
|
5
|
5
|
24
|
26
|
19
|
6
|
4
|
14
|
45
|
16
|
12
|
|
Overall Study
Received at Least One Dose of Study Drug
|
25
|
33
|
5
|
5
|
24
|
26
|
19
|
6
|
4
|
14
|
45
|
16
|
12
|
|
Overall Study
COMPLETED
|
25
|
33
|
5
|
5
|
24
|
26
|
19
|
6
|
4
|
14
|
45
|
16
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety Study in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Arm A Tasisulam + Gemcitabine Dose Escalation
n=25 Participants
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Confirmation
n=33 Participants
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B* Tasisulam + Docetaxel Dose Escalation
n=5 Participants
Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B1 Tasisulam + Docetaxel Dose Escalation
n=5 Participants
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam Day 4 of a 28 day cycle. Participant's may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Escalation
n=24 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Confirmation
n=26 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm C Tasisulam + Temozolomide Dose Escalation
n=19 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm C Tasisulam + Temozolomide Dose Confirmation
n=6 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D* Tasisulam + Cisplatin Dose Escalation
n=4 Participants
Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
|
Arm D Tasisulam + Cisplatin Dose Escalation
n=14 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D Tasisulam + Cisplatin Dose Confirmation
n=45 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Escalation
n=16 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Confirmation
n=12 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.2 years
n=5 Participants
|
65.5 years
n=7 Participants
|
66.3 years
n=5 Participants
|
78.8 years
n=4 Participants
|
64.2 years
n=21 Participants
|
62.7 years
n=8 Participants
|
63.3 years
n=8 Participants
|
65.7 years
n=24 Participants
|
48.46 years
n=42 Participants
|
54.88 years
n=42 Participants
|
67.36 years
n=42 Participants
|
57.84 years
n=42 Participants
|
61.63 years
n=36 Participants
|
63.6 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
117 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
117 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · African
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
22 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
197 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · East Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · West Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
45 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
234 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline to Cycle 1 (Up to Day 28)Population: All participants who received at least one dose of study drug Tasisulam in dose escalation phase and experienced a dose-limiting toxicity.
A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade 4 neutropenia lasting more than 5 days. Grade 4 neutropenia with fever or Grade 4 thrombocytopenia, regardless of duration; Grade ≥3 thrombocytopenia with bleeding, regardless of duration; Grade ≥3 nonhematologic toxicity (excluding nausea/vomiting or diarrhea that can be controlled with medication, and alopecia). Grade 3 electrolyte toxicity (for example, hypokalemia, hypophosphatemia) will not be considered a DLT unless it is considered related to the study drug or combination and does not resolve with standard replacement treatments within 42 days after Cycle 1 Day 1. A summary of other nonserious AEs and all Serious Adverse Events (SAE), regardless of causality is located in the Reported Adverse Event section.
Outcome measures
| Measure |
Arm B2 Tasisulam + Docetaxel Dose Confirmation
n=26 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm C Tasisulam + Temozolomide Dose Escalation
n=19 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm C Tasisulam + Temozolomide Dose Confirmation
n=6 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm D* Tasisulam + Cisplatin Dose Escalation
n=4 Participants
Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
|
Arm D Tasisulam + Cisplatin Dose Escalation
n=14 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D Tasisulam + Cisplatin Dose Confirmation
n=45 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Escalation
n=25 Participants
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Confirmation
n=33 Participants
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B* Tasisulam + Docetaxel Dose Escalation
n=5 Participants
Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B1 Tasisulam + Docetaxel Dose Escalation
n=5 Participants
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Escalation
n=24 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Escalation
n=16 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Confirmation
n=12 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities Cycle 1
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.Population: All participants who received at least one dose of study drug Tasisulam and had evaluable PK data
Cycle 2: predose,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.
Outcome measures
| Measure |
Arm B2 Tasisulam + Docetaxel Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm C Tasisulam + Temozolomide Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm C Tasisulam + Temozolomide Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm D* Tasisulam + Cisplatin Dose Escalation
Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
|
Arm D Tasisulam + Cisplatin Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D Tasisulam + Cisplatin Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Escalation
n=217 Participants
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Confirmation
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B* Tasisulam + Docetaxel Dose Escalation
Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B1 Tasisulam + Docetaxel Dose Escalation
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK): Concentration Maximum (Cmax)
Cycle 1
|
—
|
—
|
—
|
—
|
—
|
—
|
306 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 20.03
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic (PK): Concentration Maximum (Cmax)
Cycle 2
|
—
|
—
|
—
|
—
|
—
|
—
|
250 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 31.39
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Study Completion (Up to 2 years)Population: All participants who received study drug Tasisulam and had CR or PR tumor response at dose confirmation phase.
Best overall tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions.
Outcome measures
| Measure |
Arm B2 Tasisulam + Docetaxel Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm C Tasisulam + Temozolomide Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm C Tasisulam + Temozolomide Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm D* Tasisulam + Cisplatin Dose Escalation
Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
|
Arm D Tasisulam + Cisplatin Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D Tasisulam + Cisplatin Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Escalation
n=33 Participants
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Confirmation
n=26 Participants
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B* Tasisulam + Docetaxel Dose Escalation
n=6 Participants
Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B1 Tasisulam + Docetaxel Dose Escalation
n=45 Participants
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Escalation
n=12 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
Non-Small Cell Lung Cancer (NSCLC)
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
20.0 percentage of participants
Interval 3.7 to 50.7
|
—
|
5.0 percentage of participants
Interval 0.3 to 21.6
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
|
Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
Other
|
—
|
—
|
—
|
—
|
—
|
—
|
14.3 percentage of participants
Interval 2.6 to 38.5
|
6.3 percentage of participants
Interval 0.3 to 26.4
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
10.0 percentage of participants
Interval 0.5 to 39.4
|
14.3 percentage of participants
Interval 0.7 to 52.1
|
—
|
—
|
|
Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
Pancreas
|
—
|
—
|
—
|
—
|
—
|
—
|
13.3 percentage of participants
Interval 2.4 to 36.3
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 0.0
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
|
Percentage of Participants With a Complete (CR) or Partial Response (PR) (Best Overall Tumor Response)
Small Cell Lung Cancer (SCLC)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.1 percentage of participants
Interval 0.4 to 29.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Study Completion (Up to 2 years)Population: All participants who received at least one dose of study drug Tasisulam and experienced a Grade 3 or higher TEAE or drug toxicity possibly related to study drug.
Clinically significant effects are reported if a Grade 3 or higher treatment emergent adverse event (TEAE) and observed in ≥10% of participants or a toxicity possibly related to study drug based on Common Terminology Criteria for Adverse Events (CTCAE). A summary of other nonserious AEs and all SAEs, regardless of causality is located in the Reported Adverse Event section.
Outcome measures
| Measure |
Arm B2 Tasisulam + Docetaxel Dose Confirmation
n=26 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm C Tasisulam + Temozolomide Dose Escalation
n=19 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm C Tasisulam + Temozolomide Dose Confirmation
n=6 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm D* Tasisulam + Cisplatin Dose Escalation
n=4 Participants
Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
|
Arm D Tasisulam + Cisplatin Dose Escalation
n=14 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D Tasisulam + Cisplatin Dose Confirmation
n=45 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Escalation
n=25 Participants
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Confirmation
n=33 Participants
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B* Tasisulam + Docetaxel Dose Escalation
n=5 Participants
Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B1 Tasisulam + Docetaxel Dose Escalation
n=5 Participants
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Escalation
n=24 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Escalation
n=16 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Confirmation
n=12 Participants
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Clinically Significant Effects
TEAE >/= Grade 3
|
19 Participants
|
11 Participants
|
6 Participants
|
0 Participants
|
8 Participants
|
30 Participants
|
15 Participants
|
18 Participants
|
0 Participants
|
0 Participants
|
16 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With a Clinically Significant Effects
Toxicity >/= Grade 3
|
26 Participants
|
13 Participants
|
6 Participants
|
1 Participants
|
7 Participants
|
30 Participants
|
13 Participants
|
18 Participants
|
5 Participants
|
4 Participants
|
18 Participants
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Cycle 1: predose,0,30min,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.Population: All participants who received at least one dose of study drug Tasisulam and had evaluable PK data.
Cycle 2: predose,1h start of infusion, end of infusion, 30min,2h,4h,6h,22h,166h,334h,698h end of infusion.
Outcome measures
| Measure |
Arm B2 Tasisulam + Docetaxel Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm C Tasisulam + Temozolomide Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm C Tasisulam + Temozolomide Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm D* Tasisulam + Cisplatin Dose Escalation
Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
|
Arm D Tasisulam + Cisplatin Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D Tasisulam + Cisplatin Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Escalation
n=217 Participants
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Confirmation
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B* Tasisulam + Docetaxel Dose Escalation
Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B1 Tasisulam + Docetaxel Dose Escalation
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Escalation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Confirmation
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Area Under the Curve Albumin (AUCalb)
Cycle 1
|
—
|
—
|
—
|
—
|
—
|
—
|
946 micrograms*hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 427.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PK: Area Under the Curve Albumin (AUCalb)
Cycle 2
|
—
|
—
|
—
|
—
|
—
|
—
|
648 micrograms*hour/milliliter (µg*h/mL)
Geometric Coefficient of Variation 765.92
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Arm A Tasisulam + Gemcitabine Dose Escalation
Serious events: 9 serious events
Other events: 24 other events
Deaths: 2 deaths
Arm A Tasisulam + Gemcitabine Dose Confirmation
Serious events: 14 serious events
Other events: 33 other events
Deaths: 8 deaths
Arm B* Tasisulam + Docetaxel Dose Escalation
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Arm B1 Tasisulam + Docetaxel Dose Escalation
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Arm B2 Tasisulam + Docetaxel Dose Escalation
Serious events: 9 serious events
Other events: 24 other events
Deaths: 0 deaths
Arm B2 Tasisulam + Docetaxel Dose Confirmation
Serious events: 12 serious events
Other events: 26 other events
Deaths: 4 deaths
Arm C Tasisulam + Temozolomide Dose Escalation
Serious events: 8 serious events
Other events: 19 other events
Deaths: 3 deaths
Arm C Tasisulam + Temozolomide Dose Confirmation
Serious events: 4 serious events
Other events: 6 other events
Deaths: 3 deaths
Arm D* Tasisulam + Cisplatin Dose Escalation
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Arm D Tasisulam+ Cisplatin Dose Escalation
Serious events: 4 serious events
Other events: 14 other events
Deaths: 2 deaths
Arm D Tasisulam+ Cisplatin Dose Confirmation
Serious events: 19 serious events
Other events: 43 other events
Deaths: 7 deaths
Arm E Tasisulam + Erlotinib Dose Escalation
Serious events: 6 serious events
Other events: 16 other events
Deaths: 3 deaths
Arm E Tasisulam + Erlotinib Dose Confirmation
Serious events: 7 serious events
Other events: 11 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm A Tasisulam + Gemcitabine Dose Escalation
n=25 participants at risk
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Confirmation
n=33 participants at risk
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B* Tasisulam + Docetaxel Dose Escalation
n=5 participants at risk
Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B1 Tasisulam + Docetaxel Dose Escalation
n=5 participants at risk
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Escalation
n=24 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Confirmation
n=26 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm C Tasisulam + Temozolomide Dose Escalation
n=19 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm C Tasisulam + Temozolomide Dose Confirmation
n=6 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D* Tasisulam + Cisplatin Dose Escalation
n=4 participants at risk
Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
|
Arm D Tasisulam+ Cisplatin Dose Escalation
n=14 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D Tasisulam+ Cisplatin Dose Confirmation
n=45 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Escalation
n=16 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Confirmation
n=12 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Adrenal haemorrhage
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/25
|
6.1%
2/33 • Number of events 3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/13
|
7.1%
1/14 • Number of events 2
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
0.00%
0/9
|
0.00%
0/15
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/24
|
0.00%
0/7
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
2/25 • Number of events 4
|
6.1%
2/33 • Number of events 3
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 5
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
6.7%
3/45 • Number of events 4
|
0.00%
0/16
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.0%
1/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
6.7%
3/45 • Number of events 4
|
0.00%
0/16
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 2
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/25
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
12.5%
3/24 • Number of events 3
|
0.00%
0/26
|
15.8%
3/19 • Number of events 4
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
1/25 • Number of events 1
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
4.2%
1/24 • Number of events 2
|
0.00%
0/26
|
15.8%
3/19 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
4.4%
2/45 • Number of events 2
|
0.00%
0/16
|
16.7%
2/12 • Number of events 4
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/25
|
6.1%
2/33 • Number of events 3
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 2
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
0.00%
0/16
|
0.00%
0/12
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Ileus
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Intestinal obstruction
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 3
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Jejunal ulcer
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/25
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 3
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
4.0%
1/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
8.0%
2/25 • Number of events 5
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
6.7%
3/45 • Number of events 5
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Asthenia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Complication associated with device
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
General physical health deterioration
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Mucosal inflammation
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Oedema peripheral
|
0.00%
0/25
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Pyrexia
|
8.0%
2/25 • Number of events 3
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Hepatobiliary disorders
Bile duct obstruction
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Cellulitis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Endocarditis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Infection
|
4.0%
1/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/25
|
0.00%
0/33
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
7.7%
2/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Postoperative wound infection
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Sepsis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Septic shock
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Systemic candida
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Acute haemolytic transfusion reaction
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Investigations
Platelet count decreased
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
6.7%
3/45 • Number of events 4
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.0%
1/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Vascular disorders
Thrombosis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 2
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
0.00%
0/16
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/25
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Aphasia
|
4.0%
1/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 2
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 2
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Presyncope
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Seizure
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Psychiatric disorders
Confusional state
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 2
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 2
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/25
|
0.00%
0/33
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
8.3%
2/24 • Number of events 2
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/25
|
6.1%
2/33 • Number of events 4
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
Other adverse events
| Measure |
Arm A Tasisulam + Gemcitabine Dose Escalation
n=25 participants at risk
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm A Tasisulam + Gemcitabine Dose Confirmation
n=33 participants at risk
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B* Tasisulam + Docetaxel Dose Escalation
n=5 participants at risk
Tasisulam and Docetaxel 60 mg/m2 administered concurrently intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B1 Tasisulam + Docetaxel Dose Escalation
n=5 participants at risk
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam Day 4 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Escalation
n=24 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm B2 Tasisulam + Docetaxel Dose Confirmation
n=26 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm C Tasisulam + Temozolomide Dose Escalation
n=19 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met
|
Arm C Tasisulam + Temozolomide Dose Confirmation
n=6 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Temozolomide 200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D* Tasisulam + Cisplatin Dose Escalation
n=4 participants at risk
Tasisulam and 75 mg/m2 cisplatin administered IV on Day 1 in 21-day cycles.
|
Arm D Tasisulam+ Cisplatin Dose Escalation
n=14 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm D Tasisulam+ Cisplatin Dose Confirmation
n=45 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Cisplatin 75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Escalation
n=16 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
Arm E Tasisulam + Erlotinib Dose Confirmation
n=12 participants at risk
Tasisulam individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Erlotinib 150 mg administered orally (PO) days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/25
|
3.0%
1/33 • Number of events 6
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
14.3%
2/14 • Number of events 13
|
4.4%
2/45 • Number of events 7
|
0.00%
0/16
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.0%
3/25 • Number of events 10
|
3.0%
1/33 • Number of events 7
|
20.0%
1/5 • Number of events 3
|
0.00%
0/5
|
8.3%
2/24 • Number of events 7
|
7.7%
2/26 • Number of events 8
|
5.3%
1/19 • Number of events 6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
11.5%
3/26 • Number of events 19
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.0%
3/25 • Number of events 5
|
3.0%
1/33 • Number of events 8
|
20.0%
1/5 • Number of events 2
|
0.00%
0/5
|
8.3%
2/24 • Number of events 4
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 8
|
6.2%
1/16 • Number of events 3
|
8.3%
1/12 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
10.5%
2/19 • Number of events 6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
4.0%
1/25 • Number of events 4
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 13
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
7.1%
1/14 • Number of events 3
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/25
|
6.1%
2/33 • Number of events 5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
8.3%
2/24 • Number of events 9
|
0.00%
0/26
|
5.3%
1/19 • Number of events 3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
8.0%
2/25 • Number of events 12
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/25
|
3.0%
1/33 • Number of events 4
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 6
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
25.0%
1/4 • Number of events 5
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/25
|
0.00%
0/33
|
40.0%
2/5 • Number of events 5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.0%
1/25 • Number of events 1
|
6.1%
2/33 • Number of events 8
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 2
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
6.2%
1/16 • Number of events 2
|
8.3%
1/12 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/25
|
6.1%
2/33 • Number of events 4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
8.3%
2/24 • Number of events 13
|
3.8%
1/26 • Number of events 11
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 7
|
6.2%
1/16 • Number of events 3
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.0%
3/25 • Number of events 10
|
18.2%
6/33 • Number of events 28
|
20.0%
1/5 • Number of events 6
|
40.0%
2/5 • Number of events 10
|
29.2%
7/24 • Number of events 43
|
30.8%
8/26 • Number of events 77
|
5.3%
1/19 • Number of events 2
|
33.3%
2/6 • Number of events 3
|
0.00%
0/4
|
7.1%
1/14 • Number of events 6
|
13.3%
6/45 • Number of events 26
|
0.00%
0/16
|
16.7%
2/12 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
4.0%
1/25 • Number of events 8
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
37.5%
6/16 • Number of events 25
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/25
|
3.0%
1/33 • Number of events 9
|
0.00%
0/5
|
0.00%
0/5
|
8.3%
2/24 • Number of events 16
|
3.8%
1/26 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
25.0%
4/16 • Number of events 19
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 4
|
6.2%
1/16 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
25.0%
3/12 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/12
|
0.00%
0/19
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/10
|
0.00%
0/17
|
25.0%
1/4 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/9
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/25
|
6.1%
2/33 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 3
|
0.00%
0/16
|
8.3%
1/12 • Number of events 3
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
28.6%
4/14 • Number of events 22
|
8.9%
4/45 • Number of events 8
|
0.00%
0/16
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/25
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 9
|
0.00%
0/45
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
Eye disorders
Chorioretinal disorder
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Anaemia
|
44.0%
11/25 • Number of events 66
|
39.4%
13/33 • Number of events 28
|
60.0%
3/5 • Number of events 5
|
80.0%
4/5 • Number of events 11
|
45.8%
11/24 • Number of events 45
|
42.3%
11/26 • Number of events 82
|
31.6%
6/19 • Number of events 21
|
33.3%
2/6 • Number of events 4
|
0.00%
0/4
|
35.7%
5/14 • Number of events 13
|
42.2%
19/45 • Number of events 71
|
50.0%
8/16 • Number of events 27
|
33.3%
4/12 • Number of events 14
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/25
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
7.7%
2/26 • Number of events 3
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.0%
4/25 • Number of events 11
|
0.00%
0/33
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
8.3%
2/24 • Number of events 6
|
15.4%
4/26 • Number of events 7
|
10.5%
2/19 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
7.1%
1/14 • Number of events 4
|
8.9%
4/45 • Number of events 12
|
0.00%
0/16
|
16.7%
2/12 • Number of events 5
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 6
|
3.8%
1/26 • Number of events 1
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
0.00%
0/16
|
8.3%
1/12 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
52.0%
13/25 • Number of events 48
|
21.2%
7/33 • Number of events 30
|
80.0%
4/5 • Number of events 5
|
60.0%
3/5 • Number of events 17
|
58.3%
14/24 • Number of events 59
|
65.4%
17/26 • Number of events 84
|
31.6%
6/19 • Number of events 16
|
33.3%
2/6 • Number of events 3
|
25.0%
1/4 • Number of events 10
|
35.7%
5/14 • Number of events 24
|
42.2%
19/45 • Number of events 64
|
12.5%
2/16 • Number of events 6
|
41.7%
5/12 • Number of events 11
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
48.0%
12/25 • Number of events 41
|
33.3%
11/33 • Number of events 28
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
20.8%
5/24 • Number of events 7
|
42.3%
11/26 • Number of events 30
|
42.1%
8/19 • Number of events 33
|
66.7%
4/6 • Number of events 8
|
0.00%
0/4
|
42.9%
6/14 • Number of events 14
|
57.8%
26/45 • Number of events 89
|
25.0%
4/16 • Number of events 7
|
33.3%
4/12 • Number of events 24
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
6.7%
3/45 • Number of events 4
|
0.00%
0/16
|
0.00%
0/12
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Cardiac disorders
Palpitations
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
6.7%
3/45 • Number of events 4
|
0.00%
0/16
|
0.00%
0/12
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 3
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/25
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
12.5%
3/24 • Number of events 4
|
7.7%
2/26 • Number of events 11
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
25.0%
1/4 • Number of events 3
|
0.00%
0/14
|
8.9%
4/45 • Number of events 4
|
12.5%
2/16 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
|
Eye disorders
Dry eye
|
4.0%
1/25 • Number of events 14
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 7
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
6.2%
1/16 • Number of events 9
|
0.00%
0/12
|
|
Eye disorders
Eye discharge
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 3
|
0.00%
0/16
|
0.00%
0/12
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Eye disorders
Eye pain
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 3
|
0.00%
0/16
|
0.00%
0/12
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/25
|
0.00%
0/33
|
20.0%
1/5 • Number of events 5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 3
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 3
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Eye disorders
Macular detachment
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Eye disorders
Orbital oedema
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
8.3%
2/24 • Number of events 6
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Eye disorders
Vision blurred
|
4.0%
1/25 • Number of events 4
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
7.7%
2/26 • Number of events 7
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
0.00%
0/14
|
2.2%
1/45 • Number of events 9
|
0.00%
0/16
|
0.00%
0/12
|
|
Eye disorders
Visual impairment
|
0.00%
0/25
|
6.1%
2/33 • Number of events 8
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 4
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.0%
1/25 • Number of events 2
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 3
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 9
|
0.00%
0/16
|
8.3%
1/12 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
1/25 • Number of events 1
|
6.1%
2/33 • Number of events 4
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
33.3%
2/6 • Number of events 3
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal hernia
|
4.0%
1/25 • Number of events 22
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 3
|
5.3%
1/19 • Number of events 8
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 3
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal pain
|
16.0%
4/25 • Number of events 11
|
15.2%
5/33 • Number of events 9
|
0.00%
0/5
|
40.0%
2/5 • Number of events 4
|
12.5%
3/24 • Number of events 12
|
15.4%
4/26 • Number of events 15
|
10.5%
2/19 • Number of events 4
|
16.7%
1/6 • Number of events 2
|
50.0%
2/4 • Number of events 13
|
14.3%
2/14 • Number of events 6
|
6.7%
3/45 • Number of events 11
|
12.5%
2/16 • Number of events 5
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 5
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/25
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 6
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 4
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Ascites
|
8.0%
2/25 • Number of events 4
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 4
|
2.2%
1/45 • Number of events 2
|
18.8%
3/16 • Number of events 5
|
0.00%
0/12
|
|
Gastrointestinal disorders
Constipation
|
28.0%
7/25 • Number of events 26
|
48.5%
16/33 • Number of events 64
|
20.0%
1/5 • Number of events 7
|
40.0%
2/5 • Number of events 4
|
29.2%
7/24 • Number of events 24
|
50.0%
13/26 • Number of events 57
|
36.8%
7/19 • Number of events 25
|
33.3%
2/6 • Number of events 3
|
75.0%
3/4 • Number of events 6
|
28.6%
4/14 • Number of events 9
|
24.4%
11/45 • Number of events 48
|
18.8%
3/16 • Number of events 31
|
25.0%
3/12 • Number of events 15
|
|
Gastrointestinal disorders
Diarrhoea
|
52.0%
13/25 • Number of events 22
|
27.3%
9/33 • Number of events 51
|
40.0%
2/5 • Number of events 4
|
80.0%
4/5 • Number of events 11
|
37.5%
9/24 • Number of events 18
|
26.9%
7/26 • Number of events 31
|
21.1%
4/19 • Number of events 6
|
16.7%
1/6 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
7.1%
1/14 • Number of events 2
|
28.9%
13/45 • Number of events 99
|
62.5%
10/16 • Number of events 49
|
33.3%
4/12 • Number of events 20
|
|
Gastrointestinal disorders
Dry mouth
|
4.0%
1/25 • Number of events 1
|
6.1%
2/33 • Number of events 4
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
25.0%
1/4 • Number of events 3
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
0.00%
0/16
|
16.7%
2/12 • Number of events 9
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • Number of events 3
|
3.0%
1/33 • Number of events 8
|
20.0%
1/5 • Number of events 2
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
15.4%
4/26 • Number of events 17
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
7.1%
1/14 • Number of events 2
|
4.4%
2/45 • Number of events 3
|
12.5%
2/16 • Number of events 6
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
8.0%
2/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 6
|
6.2%
1/16 • Number of events 2
|
8.3%
1/12 • Number of events 5
|
|
Gastrointestinal disorders
Flatulence
|
12.0%
3/25 • Number of events 5
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
14.3%
2/14 • Number of events 8
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/25
|
6.1%
2/33 • Number of events 11
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
7.7%
2/26 • Number of events 43
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 11
|
6.2%
1/16 • Number of events 9
|
16.7%
2/12 • Number of events 5
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
5.3%
1/19 • Number of events 8
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.0%
2/25 • Number of events 2
|
6.1%
2/33 • Number of events 12
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 6
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 4
|
0.00%
0/12
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.0%
2/25 • Number of events 4
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
40.0%
10/25 • Number of events 50
|
21.2%
7/33 • Number of events 42
|
60.0%
3/5 • Number of events 3
|
60.0%
3/5 • Number of events 7
|
41.7%
10/24 • Number of events 21
|
38.5%
10/26 • Number of events 72
|
36.8%
7/19 • Number of events 22
|
0.00%
0/6
|
75.0%
3/4 • Number of events 20
|
28.6%
4/14 • Number of events 13
|
42.2%
19/45 • Number of events 126
|
37.5%
6/16 • Number of events 11
|
33.3%
4/12 • Number of events 6
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
4.0%
1/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
4.0%
1/25 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
40.0%
2/5 • Number of events 3
|
8.3%
2/24 • Number of events 11
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Pancreatic insufficiency
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
16.0%
4/25 • Number of events 6
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
4/24 • Number of events 7
|
11.5%
3/26 • Number of events 11
|
5.3%
1/19 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
2.2%
1/45 • Number of events 2
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
Gastrointestinal disorders
Toothache
|
4.0%
1/25 • Number of events 5
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
24.0%
6/25 • Number of events 13
|
9.1%
3/33 • Number of events 4
|
40.0%
2/5 • Number of events 3
|
20.0%
1/5 • Number of events 2
|
29.2%
7/24 • Number of events 15
|
15.4%
4/26 • Number of events 14
|
21.1%
4/19 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 2
|
14.3%
2/14 • Number of events 6
|
33.3%
15/45 • Number of events 44
|
12.5%
2/16 • Number of events 3
|
50.0%
6/12 • Number of events 11
|
|
General disorders
Application site dermatitis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Asthenia
|
20.0%
5/25 • Number of events 12
|
12.1%
4/33 • Number of events 14
|
0.00%
0/5
|
0.00%
0/5
|
12.5%
3/24 • Number of events 9
|
3.8%
1/26 • Number of events 1
|
15.8%
3/19 • Number of events 7
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
0.00%
0/14
|
20.0%
9/45 • Number of events 78
|
12.5%
2/16 • Number of events 3
|
16.7%
2/12 • Number of events 4
|
|
General disorders
Chest discomfort
|
8.0%
2/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 4
|
0.00%
0/26
|
5.3%
1/19 • Number of events 3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Chest pain
|
4.0%
1/25 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Chills
|
8.0%
2/25 • Number of events 2
|
9.1%
3/33 • Number of events 3
|
40.0%
2/5 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
10.5%
2/19 • Number of events 2
|
0.00%
0/6
|
25.0%
1/4 • Number of events 4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Decreased activity
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
General disorders
Discomfort
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Face oedema
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 4
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
General disorders
Fatigue
|
68.0%
17/25 • Number of events 76
|
51.5%
17/33 • Number of events 90
|
60.0%
3/5 • Number of events 11
|
80.0%
4/5 • Number of events 8
|
66.7%
16/24 • Number of events 70
|
61.5%
16/26 • Number of events 97
|
68.4%
13/19 • Number of events 36
|
16.7%
1/6 • Number of events 2
|
75.0%
3/4 • Number of events 12
|
50.0%
7/14 • Number of events 37
|
60.0%
27/45 • Number of events 163
|
43.8%
7/16 • Number of events 26
|
41.7%
5/12 • Number of events 20
|
|
General disorders
Feeling hot
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Gait disturbance
|
0.00%
0/25
|
0.00%
0/33
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 6
|
0.00%
0/16
|
8.3%
1/12 • Number of events 2
|
|
General disorders
Influenza like illness
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 4
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Infusion site pain
|
4.0%
1/25 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
7.7%
2/26 • Number of events 3
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
8.9%
4/45 • Number of events 8
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Injection site pain
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Malaise
|
0.00%
0/25
|
0.00%
0/33
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Mucosal inflammation
|
24.0%
6/25 • Number of events 11
|
12.1%
4/33 • Number of events 9
|
20.0%
1/5 • Number of events 3
|
20.0%
1/5 • Number of events 1
|
29.2%
7/24 • Number of events 20
|
15.4%
4/26 • Number of events 42
|
15.8%
3/19 • Number of events 4
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
12.5%
2/16 • Number of events 13
|
8.3%
1/12 • Number of events 8
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/25
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
8.9%
4/45 • Number of events 7
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Oedema
|
0.00%
0/25
|
6.1%
2/33 • Number of events 11
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
7.1%
1/14 • Number of events 2
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Oedema peripheral
|
16.0%
4/25 • Number of events 7
|
9.1%
3/33 • Number of events 13
|
40.0%
2/5 • Number of events 6
|
40.0%
2/5 • Number of events 3
|
20.8%
5/24 • Number of events 15
|
23.1%
6/26 • Number of events 100
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
14.3%
2/14 • Number of events 2
|
13.3%
6/45 • Number of events 9
|
31.2%
5/16 • Number of events 13
|
8.3%
1/12 • Number of events 2
|
|
General disorders
Pain
|
0.00%
0/25
|
6.1%
2/33 • Number of events 6
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 4
|
4.4%
2/45 • Number of events 9
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Peripheral swelling
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
12.5%
3/24 • Number of events 11
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
8.3%
1/12 • Number of events 6
|
|
General disorders
Pyrexia
|
20.0%
5/25 • Number of events 5
|
15.2%
5/33 • Number of events 26
|
40.0%
2/5 • Number of events 5
|
0.00%
0/5
|
12.5%
3/24 • Number of events 3
|
3.8%
1/26 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
14.3%
2/14 • Number of events 4
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Temperature intolerance
|
4.0%
1/25 • Number of events 3
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
General disorders
Thirst
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Xerosis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 6
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 2
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.0%
1/25 • Number of events 3
|
9.1%
3/33 • Number of events 5
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
4.2%
1/24 • Number of events 3
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 3
|
0.00%
0/16
|
8.3%
1/12 • Number of events 3
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/25
|
6.1%
2/33 • Number of events 10
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 9
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 3
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Candida infection
|
0.00%
0/25
|
6.1%
2/33 • Number of events 3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
7.7%
2/26 • Number of events 3
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/25
|
6.1%
2/33 • Number of events 2
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 4
|
|
Infections and infestations
Cystitis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Fungal infection
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 2
|
16.7%
2/12 • Number of events 5
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Herpes zoster
|
4.0%
1/25 • Number of events 2
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 4
|
3.8%
1/26 • Number of events 2
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 8
|
0.00%
0/16
|
8.3%
1/12 • Number of events 3
|
|
Infections and infestations
Localised infection
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Nail infection
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Oral herpes
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/25
|
3.0%
1/33 • Number of events 3
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 40
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Pneumonia
|
8.0%
2/25 • Number of events 2
|
0.00%
0/33
|
20.0%
1/5 • Number of events 2
|
20.0%
1/5 • Number of events 2
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
6.7%
3/45 • Number of events 3
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Sepsis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 2
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Infections and infestations
Sinusitis
|
8.0%
2/25 • Number of events 3
|
6.1%
2/33 • Number of events 5
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 3
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 2
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 6
|
0.00%
0/12
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
2/25 • Number of events 4
|
9.1%
3/33 • Number of events 4
|
0.00%
0/5
|
0.00%
0/5
|
20.8%
5/24 • Number of events 10
|
3.8%
1/26 • Number of events 2
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Urinary tract infection
|
24.0%
6/25 • Number of events 7
|
6.1%
2/33 • Number of events 4
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
7.7%
2/26 • Number of events 2
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/14
|
6.7%
3/45 • Number of events 4
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Viral infection
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 3
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/12
|
0.00%
0/19
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/10
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/7
|
9.5%
2/21 • Number of events 3
|
0.00%
0/9
|
0.00%
0/7
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/12
|
5.3%
1/19 • Number of events 1
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/10
|
0.00%
0/17
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/9
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Contusion
|
4.0%
1/25 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
8.3%
2/24 • Number of events 4
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
12.5%
2/16 • Number of events 2
|
8.3%
1/12 • Number of events 2
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
1/25 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
0.00%
0/16
|
25.0%
3/12 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
12.0%
3/25 • Number of events 4
|
6.1%
2/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
5.3%
1/19 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 3
|
0.00%
0/16
|
16.7%
2/12 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase increased
|
4.0%
1/25 • Number of events 2
|
6.1%
2/33 • Number of events 5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
16.7%
2/12 • Number of events 4
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Blood creatine increased
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Investigations
Blood creatinine increased
|
12.0%
3/25 • Number of events 9
|
9.1%
3/33 • Number of events 5
|
40.0%
2/5 • Number of events 2
|
0.00%
0/5
|
16.7%
4/24 • Number of events 15
|
3.8%
1/26 • Number of events 1
|
10.5%
2/19 • Number of events 12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
21.4%
3/14 • Number of events 13
|
26.7%
12/45 • Number of events 66
|
0.00%
0/16
|
25.0%
3/12 • Number of events 10
|
|
Investigations
Blood urea increased
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 4
|
0.00%
0/16
|
0.00%
0/12
|
|
Investigations
Blood urine present
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/25
|
0.00%
0/33
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/25
|
6.1%
2/33 • Number of events 5
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 11
|
0.00%
0/16
|
0.00%
0/12
|
|
Investigations
International normalised ratio increased
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 3
|
0.00%
0/16
|
0.00%
0/12
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Platelet count decreased
|
4.0%
1/25 • Number of events 2
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Investigations
Precancerous cells present
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Investigations
Urine leukocyte esterase
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 3
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Investigations
Weight decreased
|
20.0%
5/25 • Number of events 13
|
15.2%
5/33 • Number of events 17
|
0.00%
0/5
|
0.00%
0/5
|
16.7%
4/24 • Number of events 7
|
3.8%
1/26 • Number of events 8
|
10.5%
2/19 • Number of events 5
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
14.3%
2/14 • Number of events 5
|
8.9%
4/45 • Number of events 8
|
18.8%
3/16 • Number of events 6
|
8.3%
1/12 • Number of events 2
|
|
Investigations
Weight increased
|
4.0%
1/25 • Number of events 7
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
8.3%
2/24 • Number of events 6
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Investigations
White blood cell count decreased
|
8.0%
2/25 • Number of events 6
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
7.7%
2/26 • Number of events 2
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.0%
7/25 • Number of events 22
|
18.2%
6/33 • Number of events 27
|
0.00%
0/5
|
40.0%
2/5 • Number of events 6
|
33.3%
8/24 • Number of events 23
|
30.8%
8/26 • Number of events 30
|
31.6%
6/19 • Number of events 19
|
33.3%
2/6 • Number of events 2
|
50.0%
2/4 • Number of events 5
|
21.4%
3/14 • Number of events 14
|
33.3%
15/45 • Number of events 36
|
56.2%
9/16 • Number of events 24
|
41.7%
5/12 • Number of events 14
|
|
Metabolism and nutrition disorders
Dehydration
|
16.0%
4/25 • Number of events 10
|
6.1%
2/33 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
25.0%
6/24 • Number of events 7
|
11.5%
3/26 • Number of events 10
|
15.8%
3/19 • Number of events 3
|
0.00%
0/6
|
0.00%
0/4
|
21.4%
3/14 • Number of events 6
|
13.3%
6/45 • Number of events 10
|
12.5%
2/16 • Number of events 4
|
33.3%
4/12 • Number of events 7
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 3
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 9
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.0%
1/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
6.2%
1/16 • Number of events 2
|
16.7%
2/12 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.0%
3/25 • Number of events 5
|
6.1%
2/33 • Number of events 6
|
0.00%
0/5
|
20.0%
1/5 • Number of events 7
|
8.3%
2/24 • Number of events 2
|
11.5%
3/26 • Number of events 5
|
5.3%
1/19 • Number of events 3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
6.7%
3/45 • Number of events 4
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 4
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.0%
3/25 • Number of events 9
|
18.2%
6/33 • Number of events 13
|
0.00%
0/5
|
40.0%
2/5 • Number of events 5
|
20.8%
5/24 • Number of events 11
|
34.6%
9/26 • Number of events 66
|
0.00%
0/19
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
28.6%
4/14 • Number of events 15
|
24.4%
11/45 • Number of events 22
|
37.5%
6/16 • Number of events 13
|
25.0%
3/12 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 2
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
11.1%
5/45 • Number of events 11
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.0%
7/25 • Number of events 13
|
12.1%
4/33 • Number of events 15
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 2
|
25.0%
6/24 • Number of events 17
|
34.6%
9/26 • Number of events 26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
21.4%
3/14 • Number of events 10
|
26.7%
12/45 • Number of events 25
|
50.0%
8/16 • Number of events 19
|
41.7%
5/12 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.0%
1/25 • Number of events 3
|
0.00%
0/33
|
0.00%
0/5
|
80.0%
4/5 • Number of events 7
|
20.8%
5/24 • Number of events 7
|
15.4%
4/26 • Number of events 19
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
20.0%
9/45 • Number of events 10
|
6.2%
1/16 • Number of events 1
|
25.0%
3/12 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.0%
2/25 • Number of events 3
|
9.1%
3/33 • Number of events 4
|
0.00%
0/5
|
0.00%
0/5
|
8.3%
2/24 • Number of events 8
|
11.5%
3/26 • Number of events 6
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 3
|
15.6%
7/45 • Number of events 9
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.0%
5/25 • Number of events 11
|
9.1%
3/33 • Number of events 5
|
0.00%
0/5
|
80.0%
4/5 • Number of events 8
|
29.2%
7/24 • Number of events 24
|
11.5%
3/26 • Number of events 7
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
22.2%
10/45 • Number of events 17
|
12.5%
2/16 • Number of events 3
|
25.0%
3/12 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
12.0%
3/25 • Number of events 4
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 4
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
4.0%
1/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 5
|
12.5%
2/16 • Number of events 3
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
4/25 • Number of events 23
|
3.0%
1/33 • Number of events 9
|
20.0%
1/5 • Number of events 3
|
0.00%
0/5
|
16.7%
4/24 • Number of events 9
|
7.7%
2/26 • Number of events 9
|
5.3%
1/19 • Number of events 14
|
0.00%
0/6
|
25.0%
1/4 • Number of events 6
|
7.1%
1/14 • Number of events 10
|
4.4%
2/45 • Number of events 4
|
6.2%
1/16 • Number of events 2
|
16.7%
2/12 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
5/25 • Number of events 14
|
12.1%
4/33 • Number of events 5
|
0.00%
0/5
|
0.00%
0/5
|
8.3%
2/24 • Number of events 13
|
23.1%
6/26 • Number of events 13
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 6
|
14.3%
2/14 • Number of events 20
|
8.9%
4/45 • Number of events 12
|
12.5%
2/16 • Number of events 4
|
16.7%
2/12 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.0%
2/25 • Number of events 7
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
4.0%
1/25 • Number of events 19
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 2
|
0.00%
0/26
|
5.3%
1/19 • Number of events 3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.0%
1/25 • Number of events 2
|
9.1%
3/33 • Number of events 9
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
7.7%
2/26 • Number of events 70
|
10.5%
2/19 • Number of events 4
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
6.7%
3/45 • Number of events 7
|
0.00%
0/16
|
8.3%
1/12 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.0%
1/25 • Number of events 2
|
6.1%
2/33 • Number of events 4
|
20.0%
1/5 • Number of events 3
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
7.7%
2/26 • Number of events 6
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
4.4%
2/45 • Number of events 3
|
12.5%
2/16 • Number of events 2
|
8.3%
1/12 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
4.0%
1/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
16.7%
2/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.0%
2/25 • Number of events 6
|
0.00%
0/33
|
20.0%
1/5 • Number of events 2
|
20.0%
1/5 • Number of events 7
|
0.00%
0/24
|
7.7%
2/26 • Number of events 2
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
25.0%
1/4 • Number of events 3
|
7.1%
1/14 • Number of events 1
|
6.7%
3/45 • Number of events 5
|
0.00%
0/16
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 5
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
7.7%
2/26 • Number of events 3
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Amnesia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
7.7%
2/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
40.0%
2/5 • Number of events 4
|
4.2%
1/24 • Number of events 1
|
11.5%
3/26 • Number of events 4
|
10.5%
2/19 • Number of events 4
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/14
|
13.3%
6/45 • Number of events 50
|
0.00%
0/16
|
50.0%
6/12 • Number of events 33
|
|
Nervous system disorders
Dysgeusia
|
8.0%
2/25 • Number of events 4
|
24.2%
8/33 • Number of events 37
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
16.7%
4/24 • Number of events 18
|
7.7%
2/26 • Number of events 8
|
15.8%
3/19 • Number of events 7
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 4
|
14.3%
2/14 • Number of events 8
|
11.1%
5/45 • Number of events 17
|
6.2%
1/16 • Number of events 2
|
16.7%
2/12 • Number of events 7
|
|
Nervous system disorders
Headache
|
12.0%
3/25 • Number of events 13
|
6.1%
2/33 • Number of events 2
|
80.0%
4/5 • Number of events 5
|
0.00%
0/5
|
12.5%
3/24 • Number of events 4
|
11.5%
3/26 • Number of events 13
|
15.8%
3/19 • Number of events 8
|
16.7%
1/6 • Number of events 2
|
25.0%
1/4 • Number of events 6
|
0.00%
0/14
|
6.7%
3/45 • Number of events 4
|
0.00%
0/16
|
25.0%
3/12 • Number of events 16
|
|
Nervous system disorders
Lethargy
|
4.0%
1/25 • Number of events 1
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 3
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 4
|
|
Nervous system disorders
Neuropathy peripheral
|
12.0%
3/25 • Number of events 7
|
6.1%
2/33 • Number of events 18
|
20.0%
1/5 • Number of events 1
|
20.0%
1/5 • Number of events 2
|
12.5%
3/24 • Number of events 7
|
15.4%
4/26 • Number of events 62
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 4
|
0.00%
0/14
|
6.7%
3/45 • Number of events 11
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
6.2%
1/16 • Number of events 24
|
0.00%
0/12
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/25
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
0.00%
0/24
|
3.8%
1/26 • Number of events 6
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
0.00%
0/14
|
4.4%
2/45 • Number of events 6
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/25
|
3.0%
1/33 • Number of events 9
|
0.00%
0/5
|
20.0%
1/5 • Number of events 3
|
4.2%
1/24 • Number of events 5
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Nervous system disorders
Syncope
|
8.0%
2/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 2
|
0.00%
0/16
|
0.00%
0/12
|
|
Product Issues
Device occlusion
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 22
|
0.00%
0/12
|
|
Psychiatric disorders
Anxiety
|
12.0%
3/25 • Number of events 3
|
6.1%
2/33 • Number of events 14
|
0.00%
0/5
|
0.00%
0/5
|
8.3%
2/24 • Number of events 4
|
15.4%
4/26 • Number of events 10
|
0.00%
0/19
|
50.0%
3/6 • Number of events 5
|
25.0%
1/4 • Number of events 2
|
21.4%
3/14 • Number of events 6
|
6.7%
3/45 • Number of events 5
|
12.5%
2/16 • Number of events 41
|
8.3%
1/12 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
8.0%
2/25 • Number of events 2
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
20.0%
1/5 • Number of events 5
|
4.2%
1/24 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 3
|
0.00%
0/16
|
0.00%
0/12
|
|
Psychiatric disorders
Depression
|
8.0%
2/25 • Number of events 7
|
6.1%
2/33 • Number of events 11
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 12
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 5
|
7.1%
1/14 • Number of events 4
|
2.2%
1/45 • Number of events 3
|
18.8%
3/16 • Number of events 7
|
8.3%
1/12 • Number of events 1
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/25
|
0.00%
0/33
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Psychiatric disorders
Insomnia
|
16.0%
4/25 • Number of events 14
|
6.1%
2/33 • Number of events 6
|
0.00%
0/5
|
20.0%
1/5 • Number of events 3
|
12.5%
3/24 • Number of events 14
|
23.1%
6/26 • Number of events 16
|
21.1%
4/19 • Number of events 11
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
7.1%
1/14 • Number of events 6
|
11.1%
5/45 • Number of events 22
|
18.8%
3/16 • Number of events 5
|
25.0%
3/12 • Number of events 22
|
|
Psychiatric disorders
Stress
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 2
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 2
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
12.0%
3/25 • Number of events 5
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 2
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 5
|
|
Renal and urinary disorders
Hydronephrosis
|
4.0%
1/25 • Number of events 2
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 3
|
|
Renal and urinary disorders
Pollakiuria
|
4.0%
1/25 • Number of events 1
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 3
|
10.5%
2/19 • Number of events 3
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
4.4%
2/45 • Number of events 9
|
6.2%
1/16 • Number of events 1
|
0.00%
0/12
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Renal and urinary disorders
Urinary hesitation
|
8.0%
2/25 • Number of events 3
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 8
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/13
|
14.3%
2/14 • Number of events 8
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
0.00%
0/9
|
0.00%
0/15
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/24
|
0.00%
0/7
|
0.00%
0/5
|
|
Reproductive system and breast disorders
Testicular pain
|
7.7%
1/13 • Number of events 2
|
0.00%
0/14
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/14
|
0.00%
0/9
|
0.00%
0/15
|
0.00%
0/3
|
0.00%
0/1
|
0.00%
0/7
|
0.00%
0/24
|
0.00%
0/7
|
0.00%
0/5
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/12
|
5.3%
1/19 • Number of events 2
|
0.00%
0/3
|
0.00%
0/2
|
0.00%
0/10
|
0.00%
0/17
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/9
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
8.0%
2/25 • Number of events 4
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 2
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.0%
4/25 • Number of events 11
|
33.3%
11/33 • Number of events 43
|
40.0%
2/5 • Number of events 5
|
0.00%
0/5
|
29.2%
7/24 • Number of events 22
|
15.4%
4/26 • Number of events 10
|
31.6%
6/19 • Number of events 13
|
16.7%
1/6 • Number of events 2
|
25.0%
1/4 • Number of events 4
|
14.3%
2/14 • Number of events 2
|
22.2%
10/45 • Number of events 39
|
0.00%
0/16
|
25.0%
3/12 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
6.7%
3/45 • Number of events 7
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
36.0%
9/25 • Number of events 29
|
27.3%
9/33 • Number of events 35
|
20.0%
1/5 • Number of events 3
|
40.0%
2/5 • Number of events 5
|
29.2%
7/24 • Number of events 20
|
30.8%
8/26 • Number of events 88
|
26.3%
5/19 • Number of events 7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
14.3%
2/14 • Number of events 4
|
22.2%
10/45 • Number of events 21
|
25.0%
4/16 • Number of events 7
|
16.7%
2/12 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
16.0%
4/25 • Number of events 15
|
6.1%
2/33 • Number of events 5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/5
|
8.3%
2/24 • Number of events 14
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 3
|
4.4%
2/45 • Number of events 6
|
6.2%
1/16 • Number of events 5
|
8.3%
1/12 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
8.3%
2/24 • Number of events 13
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
2/25 • Number of events 2
|
9.1%
3/33 • Number of events 5
|
20.0%
1/5 • Number of events 3
|
0.00%
0/5
|
8.3%
2/24 • Number of events 11
|
15.4%
4/26 • Number of events 9
|
10.5%
2/19 • Number of events 9
|
16.7%
1/6 • Number of events 2
|
25.0%
1/4 • Number of events 11
|
0.00%
0/14
|
13.3%
6/45 • Number of events 6
|
12.5%
2/16 • Number of events 9
|
8.3%
1/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.0%
1/25 • Number of events 2
|
6.1%
2/33 • Number of events 14
|
0.00%
0/5
|
40.0%
2/5 • Number of events 3
|
4.2%
1/24 • Number of events 2
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
12.5%
2/16 • Number of events 5
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
7.1%
1/14 • Number of events 5
|
4.4%
2/45 • Number of events 11
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.0%
3/25 • Number of events 7
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
12.5%
3/24 • Number of events 6
|
3.8%
1/26 • Number of events 5
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
6.7%
3/45 • Number of events 3
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/25
|
0.00%
0/33
|
20.0%
1/5 • Number of events 5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
21.4%
3/14 • Number of events 7
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 1
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.0%
4/25 • Number of events 5
|
12.1%
4/33 • Number of events 13
|
60.0%
3/5 • Number of events 5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
16.7%
1/6 • Number of events 3
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
0.00%
0/16
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/25
|
0.00%
0/33
|
20.0%
1/5 • Number of events 2
|
20.0%
1/5 • Number of events 3
|
4.2%
1/24 • Number of events 8
|
7.7%
2/26 • Number of events 5
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 9
|
0.00%
0/16
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
4.0%
1/25 • Number of events 3
|
6.1%
2/33 • Number of events 4
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 2
|
6.2%
1/16 • Number of events 6
|
8.3%
1/12 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
16.7%
2/12 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25
|
3.0%
1/33 • Number of events 1
|
0.00%
0/5
|
0.00%
0/5
|
8.3%
2/24 • Number of events 9
|
7.7%
2/26 • Number of events 8
|
15.8%
3/19 • Number of events 6
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
2/25 • Number of events 8
|
6.1%
2/33 • Number of events 10
|
0.00%
0/5
|
0.00%
0/5
|
33.3%
8/24 • Number of events 17
|
7.7%
2/26 • Number of events 8
|
10.5%
2/19 • Number of events 6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
31.2%
5/16 • Number of events 18
|
58.3%
7/12 • Number of events 45
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
12.5%
2/16 • Number of events 4
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 13
|
0.00%
0/19
|
0.00%
0/6
|
25.0%
1/4 • Number of events 3
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
20.0%
1/5 • Number of events 5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 3
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
3.8%
1/26 • Number of events 5
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Vascular disorders
Deep vein thrombosis
|
8.0%
2/25 • Number of events 5
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
8.3%
2/24 • Number of events 5
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
Vascular disorders
Flushing
|
4.0%
1/25 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
20.0%
1/5 • Number of events 3
|
0.00%
0/5
|
8.3%
2/24 • Number of events 4
|
0.00%
0/26
|
5.3%
1/19 • Number of events 1
|
0.00%
0/6
|
25.0%
1/4 • Number of events 2
|
0.00%
0/14
|
0.00%
0/45
|
12.5%
2/16 • Number of events 5
|
0.00%
0/12
|
|
Vascular disorders
Haematoma
|
0.00%
0/25
|
0.00%
0/33
|
20.0%
1/5 • Number of events 5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Vascular disorders
Hot flush
|
0.00%
0/25
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 9
|
0.00%
0/16
|
0.00%
0/12
|
|
Vascular disorders
Hypertension
|
4.0%
1/25 • Number of events 7
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
4.2%
1/24 • Number of events 3
|
0.00%
0/26
|
5.3%
1/19 • Number of events 2
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 2
|
4.4%
2/45 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Vascular disorders
Hypotension
|
28.0%
7/25 • Number of events 9
|
6.1%
2/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
8.3%
2/24 • Number of events 2
|
11.5%
3/26 • Number of events 4
|
10.5%
2/19 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
6.7%
3/45 • Number of events 4
|
18.8%
3/16 • Number of events 7
|
8.3%
1/12 • Number of events 2
|
|
Vascular disorders
Pallor
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
0.00%
0/45
|
0.00%
0/16
|
0.00%
0/12
|
|
Vascular disorders
Phlebitis
|
4.0%
1/25 • Number of events 2
|
3.0%
1/33 • Number of events 2
|
0.00%
0/5
|
0.00%
0/5
|
8.3%
2/24 • Number of events 3
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 1
|
0.00%
0/16
|
0.00%
0/12
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
2.2%
1/45 • Number of events 7
|
6.2%
1/16 • Number of events 6
|
0.00%
0/12
|
|
Vascular disorders
Thrombosis
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 2
|
0.00%
0/12
|
|
Vascular disorders
Vasodilatation
|
0.00%
0/25
|
0.00%
0/33
|
0.00%
0/5
|
0.00%
0/5
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/19
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/14
|
0.00%
0/45
|
6.2%
1/16 • Number of events 17
|
0.00%
0/12
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60