Trial Outcomes & Findings for A Phase 1 Study in Patients With Solid Tumors (NCT NCT01215916)
NCT ID: NCT01215916
Last Updated: 2019-03-15
Results Overview
Based on maximum tolerated dose (MTD) in Cycle 1: highest dose where \<33% participants (pts) had dose-limiting toxicity (DLT). DLTs were adverse events (AE) possibly related to study drug or AEs that met any of National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTAE): Grade (G) 4 neutropenia lasting ≥5 days; G4 neutropenia with fever, G4 thrombocytopenia, G3 thrombocytopenia with bleeding, ≥G3 non-hematologic toxicity (except nausea/vomiting and diarrhea controlled by medication; electrolyte toxicity resolved with standard replacement treatment; alopecia; and elevated alanine aminotransferase or aspartate aminotransferase with preexisting hepatic metastasis, if agreed by investigator). Investigators, with sponsor, could declare a DLT if pt experienced increasing toxicity during treatment and it was clear that further treatment would expose pt to excessive risk. Enrollment was stopped during the dose-escalation phase, thus further dose-escalation was not explored.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
Baseline to toxicity [up to end of Cycle 1 (cycle = 21 or 28 days)]
Results posted on
2019-03-15
Participant Flow
Study planned for dose-escalation followed by dose-confirmation phase. Enrollment stopped before anyone entered dose-confirmation phase. Participant (pt) Flow presents pt disposition during dose-escalation \& provide reasons for pts who discontinued treatment. All pts who received atleast 1dose of study drug were considered to have completed study.
Participant milestones
| Measure |
LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day 1
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL and 375 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL and 500 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
5
|
3
|
6
|
6
|
4
|
9
|
3
|
2
|
|
Overall Study
Received at Least 1 Dose of Either Drug
|
1
|
5
|
3
|
6
|
6
|
4
|
9
|
3
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
3
|
6
|
6
|
4
|
9
|
3
|
2
|
Reasons for withdrawal
| Measure |
LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day 1
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL and 375 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL and 500 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
0
|
2
|
1
|
2
|
5
|
4
|
5
|
3
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
1
|
0
|
0
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
2
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 1 Study in Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day 1
n=1 Participants
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL and 375 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1
n=5 Participants
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL and 500 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
n=3 Participants
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
n=6 Participants
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4
n=6 Participants
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4
n=4 Participants
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
n=9 Participants
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met
|
Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
n=3 Participants
Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4
n=2 Participants
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.63 years
STANDARD_DEVIATION NA • n=5 Participants
|
63.13 years
STANDARD_DEVIATION 11.54 • n=7 Participants
|
60.36 years
STANDARD_DEVIATION 9.39 • n=5 Participants
|
60.91 years
STANDARD_DEVIATION 10.47 • n=4 Participants
|
59.52 years
STANDARD_DEVIATION 11.00 • n=21 Participants
|
58.26 years
STANDARD_DEVIATION 6.22 • n=8 Participants
|
50.50 years
STANDARD_DEVIATION 14.55 • n=8 Participants
|
65.26 years
STANDARD_DEVIATION 5.80 • n=24 Participants
|
68.27 years
STANDARD_DEVIATION 0.07 • n=42 Participants
|
59.02 years
STANDARD_DEVIATION 11.25 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
African
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
East 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
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline to toxicity [up to end of Cycle 1 (cycle = 21 or 28 days)]Population: Enrollment was stopped during the dose-escalation phase and it was too early to assess the recommended dose for Phase 2 or to estimate the MTD, therefore zero participants were analyzed.
Based on maximum tolerated dose (MTD) in Cycle 1: highest dose where \<33% participants (pts) had dose-limiting toxicity (DLT). DLTs were adverse events (AE) possibly related to study drug or AEs that met any of National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTAE): Grade (G) 4 neutropenia lasting ≥5 days; G4 neutropenia with fever, G4 thrombocytopenia, G3 thrombocytopenia with bleeding, ≥G3 non-hematologic toxicity (except nausea/vomiting and diarrhea controlled by medication; electrolyte toxicity resolved with standard replacement treatment; alopecia; and elevated alanine aminotransferase or aspartate aminotransferase with preexisting hepatic metastasis, if agreed by investigator). Investigators, with sponsor, could declare a DLT if pt experienced increasing toxicity during treatment and it was clear that further treatment would expose pt to excessive risk. Enrollment was stopped during the dose-escalation phase, thus further dose-escalation was not explored.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)Population: All enrolled participants: those who received 1 or more doses of LY573636 or pemetrexed.
Clinically significant effects were defined as serious and other non-serious adverse events (AEs) regardless of causality. A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Pemetrexed Followed by LY573636
n=1 Participants
Pemetrexed on Day 1 and LY573636 on Day 4.
LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 micrograms per milliliter (ug/mL) up to 360 µg/mL. Intravenous dosing was completed once each 28-day cycle.
Pemetrexed: 375 milligrams per square meter (mg/m\^2) to 500 mg/m\^2; intravenous dosing was completed once each 28-day cycle.
Participants were pretreated with folic acid \[350 micrograms (µg) to 1000 µg orally, daily\], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone \[4 milligrams (mg) orally, twice daily or equivalent\].
Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
LY573636 Followed by Pemetrexed
n=5 Participants
LY573636 on Day 1 and pemetrexed on Day 4.
LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 ug/mL up to 360 µg/mL. Intravenous dosing was completed once each 28-day cycle.
Pemetrexed: 375 mg/m\^2 to 500 mg/m\^2; intravenous dosing was completed once each 28-day cycle.
Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).
Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
LY573636 and Pemetrexed on Day 1
n=3 Participants
LY573636 and pemetrexed on Day 1.
LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 ug/mL up to 360 µg/mL. Intravenous dosing was completed once each 21-day cycle.
Pemetrexed: 375 mg/m\^2 to 500 mg/m\^2. Intravenous dosing was completed once each 21-day cycle.
Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).
Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
n=6 Participants
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4
n=6 Participants
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4
n=4 Participants
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
n=9 Participants
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
n=3 Participants
Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4
n=2 Participants
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Effects
Serious AEs
|
1 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Effects
Non-Serious AEs
|
1 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
9 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to progressive disease (up to 1 year of treatment plus 30-day follow-up)Population: All enrolled participants: those who received 1 or more doses of LY573636 or pemetrexed.
Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and confirmed by repeat assessment. Complete Response (CR) was defined as the disappearance of all target lesions and the normalization of tumor marker levels for non-target lesions; Partial Response (PR) was defined as at least a 30% decrease in the sum of the longest diameter of target lesions. Percentage of participants with a tumor response = (number of participants with CR or PR/number of enrolled participants)\*100.
Outcome measures
| Measure |
Pemetrexed Followed by LY573636
n=18 Participants
Pemetrexed on Day 1 and LY573636 on Day 4.
LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 micrograms per milliliter (ug/mL) up to 360 µg/mL. Intravenous dosing was completed once each 28-day cycle.
Pemetrexed: 375 milligrams per square meter (mg/m\^2) to 500 mg/m\^2; intravenous dosing was completed once each 28-day cycle.
Participants were pretreated with folic acid \[350 micrograms (µg) to 1000 µg orally, daily\], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone \[4 milligrams (mg) orally, twice daily or equivalent\].
Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
LY573636 Followed by Pemetrexed
n=15 Participants
LY573636 on Day 1 and pemetrexed on Day 4.
LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 ug/mL up to 360 µg/mL. Intravenous dosing was completed once each 28-day cycle.
Pemetrexed: 375 mg/m\^2 to 500 mg/m\^2; intravenous dosing was completed once each 28-day cycle.
Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).
Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
LY573636 and Pemetrexed on Day 1
n=6 Participants
LY573636 and pemetrexed on Day 1.
LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 ug/mL up to 360 µg/mL. Intravenous dosing was completed once each 21-day cycle.
Pemetrexed: 375 mg/m\^2 to 500 mg/m\^2. Intravenous dosing was completed once each 21-day cycle.
Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).
Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Tumor Response
|
0.0 percentage of participants
|
13.3 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime)Population: Participants who had at least 1 evaluable Cmax pharmacokinetic sample.
Outcome measures
| Measure |
Pemetrexed Followed by LY573636
n=37 Participants
Pemetrexed on Day 1 and LY573636 on Day 4.
LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 micrograms per milliliter (ug/mL) up to 360 µg/mL. Intravenous dosing was completed once each 28-day cycle.
Pemetrexed: 375 milligrams per square meter (mg/m\^2) to 500 mg/m\^2; intravenous dosing was completed once each 28-day cycle.
Participants were pretreated with folic acid \[350 micrograms (µg) to 1000 µg orally, daily\], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone \[4 milligrams (mg) orally, twice daily or equivalent\].
Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
LY573636 Followed by Pemetrexed
LY573636 on Day 1 and pemetrexed on Day 4.
LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 ug/mL up to 360 µg/mL. Intravenous dosing was completed once each 28-day cycle.
Pemetrexed: 375 mg/m\^2 to 500 mg/m\^2; intravenous dosing was completed once each 28-day cycle.
Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).
Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
LY573636 and Pemetrexed on Day 1
LY573636 and pemetrexed on Day 1.
LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 ug/mL up to 360 µg/mL. Intravenous dosing was completed once each 21-day cycle.
Pemetrexed: 375 mg/m\^2 to 500 mg/m\^2. Intravenous dosing was completed once each 21-day cycle.
Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).
Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics, Concentration Maximum (Cmax) of LY573636
Cycle 1
|
264.285 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 18.465
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics, Concentration Maximum (Cmax) of LY573636
Cycle 2
|
225.588 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 24.061
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2 on Day 4 (prior to and at the end of LY573636 infusion, 2 and 4 hours post LY573636 infusion), Day 8 (anytime), Day 15 (anytime)Population: Participants who had at least 1 evaluable AUCalb pharmacokinetic sample.
Area under the concentration-time curve above the albumin corrected threshold (AUCalb) is provided for LY573636, which has been found to be highly bound to albumin. AUCalb is a surrogate measure of exposure to unbound (free) LY573636.
Outcome measures
| Measure |
Pemetrexed Followed by LY573636
n=36 Participants
Pemetrexed on Day 1 and LY573636 on Day 4.
LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 micrograms per milliliter (ug/mL) up to 360 µg/mL. Intravenous dosing was completed once each 28-day cycle.
Pemetrexed: 375 milligrams per square meter (mg/m\^2) to 500 mg/m\^2; intravenous dosing was completed once each 28-day cycle.
Participants were pretreated with folic acid \[350 micrograms (µg) to 1000 µg orally, daily\], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone \[4 milligrams (mg) orally, twice daily or equivalent\].
Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
LY573636 Followed by Pemetrexed
LY573636 on Day 1 and pemetrexed on Day 4.
LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 ug/mL up to 360 µg/mL. Intravenous dosing was completed once each 28-day cycle.
Pemetrexed: 375 mg/m\^2 to 500 mg/m\^2; intravenous dosing was completed once each 28-day cycle.
Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).
Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
LY573636 and Pemetrexed on Day 1
LY573636 and pemetrexed on Day 1.
LY573636: Individualized dosing was dependent on a participant's height, weight, and gender and was adjusted to target a specific LY573636 concentration corrected for a participant's laboratory parameters. The targeted drug concentration range for LY573636 dosing was 300 ug/mL up to 360 µg/mL. Intravenous dosing was completed once each 21-day cycle.
Pemetrexed: 375 mg/m\^2 to 500 mg/m\^2. Intravenous dosing was completed once each 21-day cycle.
Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent).
Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics, Area Under the Curve (AUC) of LY573636
Cycle 1
|
132.783 hour*micrograms per milliliter (h*µg/mL)
Geometric Coefficient of Variation 265.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics, Area Under the Curve (AUC) of LY573636
Cycle 2
|
68.813 hour*micrograms per milliliter (h*µg/mL)
Geometric Coefficient of Variation 1840.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day1
n=1 participants at risk
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL and 375 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1
n=5 participants at risk
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL and 500 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
n=3 participants at risk
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
n=6 participants at risk
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4
n=6 participants at risk
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4
n=4 participants at risk
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
n=9 participants at risk
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
n=3 participants at risk
Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4
n=2 participants at risk
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
1/1 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Ileus
|
100.0%
1/1 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Malaise
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Multi-organ failure
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Pain
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
2/4 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Pneumonia
|
100.0%
1/1 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
2/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
Other adverse events
| Measure |
LY573636, 300µg/mL Plus Pemetrexed, 375mg/m2 on Day1
n=1 participants at risk
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL and 375 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 340 µg/mL Plus Pemetrexed, 500 mg/m2 on Day 1
n=5 participants at risk
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL and 500 mg/m2 of pemetrexed administered IV over 10 minutes both on Day 1 of a 21-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 300 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
n=3 participants at risk
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 375 mg/m2 on Day4
n=6 participants at risk
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 1 and 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
LY573636, 320 µg/mL on Day1 Plus Pemetrexed, 500 mg/m2 on Day4
n=6 participants at risk
Participants received a combination of LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 1 and 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 300 µg/mL on Day4
n=4 participants at risk
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 300 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
n=9 participants at risk
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 500 mg/m2 on Day1 Plus LY573636, 320 µg/mL on Day4
n=3 participants at risk
Participants received a combination of 500 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 320 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
Pemetrexed, 375 mg/m2 on Day1 Plus LY573636, 340 µg/mL on Day4
n=2 participants at risk
Participants received a combination of 375 mg/m2 of pemetrexed administered IV over 10 minutes on Day 1 and LY573636 administered over a 2-hour intravenous (IV) infusion to target a Cmax of 340 µg/mL on day 4 of a 28-day cycle. Participants were pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). Participants continued on study drug (LY573636 and pemetrexed) until disease progression, unacceptable toxicity, or if any other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 10 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 7 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
2/4 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Surgical and medical procedures
Nephrostomy tube placement
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Surgical and medical procedures
Stent placement
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 7 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
1/1 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 10 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
3/9 • Number of events 9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Blood and lymphatic system disorders
Leukopenia
|
100.0%
1/1 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
3/9 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
80.0%
4/5 • Number of events 9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
22.2%
2/9 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
1/1 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Cardiac disorders
Sinus tachycardia
|
100.0%
1/1 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 7 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
1/1 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
2/4 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
3/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
3/6 • Number of events 9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
22.2%
2/9 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
60.0%
3/5 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
22.2%
2/9 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
60.0%
3/5 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
100.0%
3/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
2/4 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
55.6%
5/9 • Number of events 7 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
22.2%
2/9 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Periproctitis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
3/9 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Axillary pain
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Chest pain
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Chills
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Device malfunction
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Early satiety
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 11 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Face oedema
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
80.0%
4/5 • Number of events 11 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 11 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
4/6 • Number of events 11 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
3/6 • Number of events 8 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
2/4 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
55.6%
5/9 • Number of events 11 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Injection site reaction
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Malaise
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Oedema
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Oedema peripheral
|
100.0%
1/1 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 7 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
2/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Pain
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
60.0%
3/5 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
22.2%
2/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
General disorders
Spinal pain
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Device related infection
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
22.2%
2/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
—
0/0 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
3/6 • Number of events 10 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
22.2%
2/9 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 8 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
2/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
3/6 • Number of events 9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
22.2%
2/9 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Heart rate increased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Transaminases increased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Urine colour abnormal
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
Weight increased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 10 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
3/6 • Number of events 6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Dehydration
|
100.0%
1/1 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
60.0%
3/5 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 7 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
44.4%
4/9 • Number of events 7 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 13 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
3/9 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
2/4 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
3/9 • Number of events 7 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
22.2%
2/9 • Number of events 7 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
44.4%
4/9 • Number of events 8 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 8 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 7 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
100.0%
1/1 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
100.0%
3/3 • Number of events 8 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
3/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
40.0%
2/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
22.2%
2/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 7 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 12 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
22.2%
2/9 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
1/2 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
100.0%
1/1 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
—
0/0 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
100.0%
1/1 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
—
0/0 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
—
0/0 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
20.0%
1/5 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
1/3 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 8 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
22.2%
2/9 • Number of events 5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 7 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
66.7%
2/3 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
33.3%
2/6 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
50.0%
2/4 • Number of events 3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
25.0%
1/4 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
16.7%
1/6 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/9 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/5 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/6 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/4 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
11.1%
1/9 • Number of events 1 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/3 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
0.00%
0/2 • Baseline to end of study (up to 1 year of treatment plus 30-day follow-up)
Deaths due to progressive disease were not considered serious adverse events and are provided in the Participant Flow.
|
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