Trial Outcomes & Findings for Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer (NCT NCT01347866)
NCT ID: NCT01347866
Last Updated: 2018-10-29
Results Overview
DLT was defined as any of the following hematologic or non-hematologic events which were attributable to the combination study drug and occurring in the first 28-day cycle: 1) Grade 4 neutropenia lasting greater than (\>)7 days; 2) Febrile neutropenia (defined as neutropenia greater than or equal to \[≥\]Grade 3 and a body temperature ≥38.5°C); 3) Grade ≥3 neutropenic infection; 4) Grade 3 thrombocytopenia with bleeding; 5) Grade 4 thrombocytopenia; 6) Grade ≥3 toxicities; 7) Persistent, intolerable toxicities which resulted in failure to deliver at least 75% of doses during the first cycle; 8) Persistent, intolerable toxicities which resulted in delay of start of Cycle 2 by more than 2 weeks of scheduled day; 9) Persistent Grade 3 QTc prolongation (QTc \>500 msec) after correction of any reversible causes.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
105 participants
Primary outcome timeframe
Baseline up to 28 days
Results posted on
2018-10-29
Participant Flow
In Arms A and B, 7 and 14 participants were screed and received study treatment, respectively. In Arm C, 45 participants were screened and 44 received study treatment. In Arm D, 39 participants were screened and 37 received study treatment. There was no Stage 2 for Arm D, the study was terminated before enrolling patients to Stage 2 for Arm D.
Participant milestones
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 2)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
1
|
1
|
7
|
7
|
3
|
6
|
4
|
31
|
7
|
3
|
4
|
7
|
7
|
3
|
4
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
1
|
7
|
7
|
3
|
6
|
4
|
31
|
7
|
3
|
4
|
7
|
7
|
3
|
4
|
2
|
Reasons for withdrawal
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 2)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
2
|
2
|
1
|
0
|
4
|
1
|
3
|
1
|
2
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
3
|
1
|
1
|
4
|
5
|
0
|
5
|
3
|
22
|
5
|
0
|
3
|
4
|
4
|
2
|
3
|
0
|
|
Overall Study
Subject refused further follow-up
|
2
|
0
|
0
|
2
|
0
|
1
|
0
|
0
|
4
|
1
|
0
|
0
|
1
|
3
|
1
|
0
|
2
|
Baseline Characteristics
Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer
Baseline characteristics by cohort
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 2)
n=31 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1B (Stage 1))
n=3 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2 (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 0.0 • n=7 Participants
|
49.0 years
STANDARD_DEVIATION 0.0 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
59.1 years
STANDARD_DEVIATION 12.9 • n=21 Participants
|
67.0 years
STANDARD_DEVIATION 3.6 • n=10 Participants
|
60.8 years
STANDARD_DEVIATION 7.2 • n=115 Participants
|
63.3 years
STANDARD_DEVIATION 14.5 • n=6 Participants
|
56.7 years
STANDARD_DEVIATION 12.4 • n=6 Participants
|
63.3 years
STANDARD_DEVIATION 5.9 • n=64 Participants
|
43.3 years
STANDARD_DEVIATION 9.1 • n=17 Participants
|
64.0 years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
55.7 years
STANDARD_DEVIATION 10.0 • n=22 Participants
|
57.9 years
STANDARD_DEVIATION 12.9 • n=8 Participants
|
61.3 years
STANDARD_DEVIATION 14.2 • n=16 Participants
|
60.0 years
STANDARD_DEVIATION 11.8 • n=135 Participants
|
54.5 years
STANDARD_DEVIATION 9.2 • n=136 Participants
|
58.5 years
STANDARD_DEVIATION 11.8 • n=44 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
13 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
44 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
18 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=22 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=16 Participants
|
2 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
58 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 daysPopulation: All enrolled participants who started treatment and who did not have a major pre-specified treatment deviation in the first cycle of treatment in Stage 1.
DLT was defined as any of the following hematologic or non-hematologic events which were attributable to the combination study drug and occurring in the first 28-day cycle: 1) Grade 4 neutropenia lasting greater than (\>)7 days; 2) Febrile neutropenia (defined as neutropenia greater than or equal to \[≥\]Grade 3 and a body temperature ≥38.5°C); 3) Grade ≥3 neutropenic infection; 4) Grade 3 thrombocytopenia with bleeding; 5) Grade 4 thrombocytopenia; 6) Grade ≥3 toxicities; 7) Persistent, intolerable toxicities which resulted in failure to deliver at least 75% of doses during the first cycle; 8) Persistent, intolerable toxicities which resulted in delay of start of Cycle 2 by more than 2 weeks of scheduled day; 9) Persistent Grade 3 QTc prolongation (QTc \>500 msec) after correction of any reversible causes.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=5 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=1 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days)
|
40.0 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
14.3 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration)Population: All enrolled participants who started treatment.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=31 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
5 participants
|
1 participants
|
1 participants
|
7 participants
|
7 participants
|
3 participants
|
6 participants
|
4 participants
|
31 participants
|
7 participants
|
3 participants
|
4 participants
|
7 participants
|
7 participants
|
3 participants
|
4 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
5 participants
|
0 participants
|
0 participants
|
2 participants
|
5 participants
|
3 participants
|
1 participants
|
2 participants
|
4 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration)Population: All enrolled participants who started treatment.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded by the NCI CTCAE (Version 4.0).
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=31 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Missing or Unknown
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Grade 5
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Grade 1
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
7 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Grade 2
|
2 participants
|
0 participants
|
0 participants
|
5 participants
|
2 participants
|
3 participants
|
4 participants
|
1 participants
|
10 participants
|
2 participants
|
2 participants
|
2 participants
|
3 participants
|
2 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Grade 3
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
5 participants
|
0 participants
|
0 participants
|
2 participants
|
10 participants
|
3 participants
|
1 participants
|
1 participants
|
2 participants
|
4 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Grade 4
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
4 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Total
|
5 participants
|
1 participants
|
1 participants
|
7 participants
|
7 participants
|
3 participants
|
6 participants
|
4 participants
|
31 participants
|
7 participants
|
3 participants
|
4 participants
|
7 participants
|
7 participants
|
3 participants
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)Population: All enrolled participants who started treatment.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities. Hematological tests included platelet count, hemoglobin, and white blood cell (WBC) count with 5- part differential.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=31 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities (Hematology)
Lymphopenia
|
5 participant
|
1 participant
|
1 participant
|
7 participant
|
7 participant
|
3 participant
|
5 participant
|
3 participant
|
22 participant
|
5 participant
|
1 participant
|
1 participant
|
6 participant
|
6 participant
|
3 participant
|
1 participant
|
1 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Hematology)
Absolute Neutrophils
|
1 participant
|
0 participant
|
0 participant
|
3 participant
|
3 participant
|
0 participant
|
2 participant
|
3 participant
|
18 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
1 participant
|
0 participant
|
1 participant
|
1 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Hematology)
Platelets
|
3 participant
|
0 participant
|
0 participant
|
4 participant
|
2 participant
|
1 participant
|
1 participant
|
3 participant
|
10 participant
|
0 participant
|
0 participant
|
2 participant
|
1 participant
|
3 participant
|
1 participant
|
1 participant
|
1 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Hematology)
White Blood Cells
|
3 participant
|
0 participant
|
0 participant
|
5 participant
|
3 participant
|
3 participant
|
3 participant
|
4 participant
|
22 participant
|
1 participant
|
0 participant
|
0 participant
|
2 participant
|
0 participant
|
1 participant
|
1 participant
|
1 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Hematology)
Anemia
|
5 participant
|
1 participant
|
1 participant
|
5 participant
|
6 participant
|
3 participant
|
6 participant
|
4 participant
|
31 participant
|
6 participant
|
3 participant
|
3 participant
|
7 participant
|
5 participant
|
3 participant
|
3 participant
|
2 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Hematology)
Hemoglobin Increased
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Hematology)
Lymphocyte Count Increased
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
1 participant
|
1 participant
|
1 participant
|
0 participant
|
1 participant
|
1 participant
|
0 participant
|
0 participant
|
0 participant
|
SECONDARY outcome
Timeframe: Baseline, Days 1 and 15 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)Population: All enrolled participants who started treatment. N=number of evaluable participants for each parameter.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 coagulation test abnormalities. Coagulation tests included partial thromboplastin time (PTT) and prothrombin time (PT) international normalized ratio (INR).
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=31 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities (Coagulation)
PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)
|
2 participant
|
0 participant
|
0 participant
|
2 participant
|
5 participant
|
2 participant
|
0 participant
|
2 participant
|
21 participant
|
2 participant
|
3 participant
|
2 participant
|
2 participant
|
5 participant
|
0 participant
|
3 participant
|
2 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Coagulation)
PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2)
|
1 participant
|
0 participant
|
1 participant
|
2 participant
|
5 participant
|
0 participant
|
1 participant
|
2 participant
|
13 participant
|
0 participant
|
1 participant
|
1 participant
|
3 participant
|
2 participant
|
1 participant
|
2 participant
|
0 participant
|
SECONDARY outcome
Timeframe: Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)Population: All enrolled participants who started treatment.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry test abnormalities. Chemistry tests included aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]), serum creatinine, total bilirubin, direct/indirect bilirubin, alkaline phosphatase, chloride, uric acid, phosphorus, calcium, magnesium, potassium, sodium, blood urea nitrogen (BUN) or urea, total protein, albumin, glucose, and insulin.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=31 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
hypernatremia
|
1 participant
|
0 participant
|
0 participant
|
0 participant
|
1 participant
|
0 participant
|
0 participant
|
1 participant
|
2 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
1 participant
|
0 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
hypophosphatemia
|
4 participant
|
1 participant
|
0 participant
|
2 participant
|
5 participant
|
0 participant
|
2 participant
|
1 participant
|
8 participant
|
1 participant
|
1 participant
|
1 participant
|
3 participant
|
3 participant
|
0 participant
|
1 participant
|
0 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
Alkaline phosphatase
|
3 participant
|
1 participant
|
1 participant
|
5 participant
|
6 participant
|
1 participant
|
3 participant
|
2 participant
|
22 participant
|
4 participant
|
3 participant
|
4 participant
|
6 participant
|
6 participant
|
3 participant
|
4 participant
|
2 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
ALT
|
3 participant
|
0 participant
|
1 participant
|
2 participant
|
3 participant
|
0 participant
|
3 participant
|
3 participant
|
13 participant
|
3 participant
|
1 participant
|
2 participant
|
5 participant
|
4 participant
|
3 participant
|
1 participant
|
2 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
AST
|
4 participant
|
0 participant
|
1 participant
|
3 participant
|
5 participant
|
0 participant
|
3 participant
|
2 participant
|
16 participant
|
4 participant
|
2 participant
|
3 participant
|
5 participant
|
6 participant
|
3 participant
|
3 participant
|
2 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
Total bilirubin
|
0 participant
|
0 participant
|
1 participant
|
2 participant
|
2 participant
|
0 participant
|
1 participant
|
1 participant
|
3 participant
|
2 participant
|
0 participant
|
2 participant
|
1 participant
|
4 participant
|
1 participant
|
1 participant
|
0 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
creatinine
|
5 participant
|
1 participant
|
0 participant
|
5 participant
|
6 participant
|
3 participant
|
5 participant
|
3 participant
|
21 participant
|
5 participant
|
2 participant
|
3 participant
|
5 participant
|
2 participant
|
3 participant
|
4 participant
|
2 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
hypercalcemia
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
1 participant
|
0 participant
|
1 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
1 participant
|
0 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
hyperglycemia
|
5 participant
|
1 participant
|
1 participant
|
6 participant
|
6 participant
|
3 participant
|
5 participant
|
3 participant
|
25 participant
|
5 participant
|
2 participant
|
3 participant
|
7 participant
|
7 participant
|
2 participant
|
4 participant
|
2 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
hyperkalemia
|
1 participant
|
0 participant
|
0 participant
|
2 participant
|
1 participant
|
0 participant
|
1 participant
|
1 participant
|
2 participant
|
1 participant
|
1 participant
|
0 participant
|
1 participant
|
2 participant
|
0 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
hypermagnesemia
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
1 participant
|
2 participant
|
2 participant
|
0 participant
|
0 participant
|
2 participant
|
1 participant
|
0 participant
|
0 participant
|
1 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
hypoalbuminemia
|
3 participant
|
1 participant
|
1 participant
|
3 participant
|
6 participant
|
0 participant
|
3 participant
|
3 participant
|
18 participant
|
3 participant
|
2 participant
|
4 participant
|
6 participant
|
6 participant
|
3 participant
|
2 participant
|
2 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
hypoglycemia
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
1 participant
|
0 participant
|
1 participant
|
0 participant
|
3 participant
|
1 participant
|
1 participant
|
1 participant
|
0 participant
|
2 participant
|
1 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
hypokalemia
|
2 participant
|
1 participant
|
1 participant
|
2 participant
|
3 participant
|
0 participant
|
0 participant
|
3 participant
|
14 participant
|
3 participant
|
1 participant
|
2 participant
|
3 participant
|
4 participant
|
0 participant
|
2 participant
|
1 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
hypomagnesemia
|
2 participant
|
0 participant
|
0 participant
|
3 participant
|
4 participant
|
2 participant
|
2 participant
|
1 participant
|
10 participant
|
2 participant
|
1 participant
|
2 participant
|
0 participant
|
2 participant
|
1 participant
|
2 participant
|
1 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
hyponatremia
|
1 participant
|
1 participant
|
0 participant
|
4 participant
|
3 participant
|
0 participant
|
1 participant
|
3 participant
|
14 participant
|
2 participant
|
2 participant
|
2 participant
|
4 participant
|
3 participant
|
1 participant
|
1 participant
|
1 participant
|
|
Number of Participants With Laboratory Test Abnormalities (Chemistry)
hypocalcemia
|
3 participant
|
0 participant
|
1 participant
|
4 participant
|
4 participant
|
1 participant
|
0 participant
|
4 participant
|
13 participant
|
2 participant
|
2 participant
|
3 participant
|
1 participant
|
4 participant
|
1 participant
|
1 participant
|
2 participant
|
SECONDARY outcome
Timeframe: Baseline, Days 1 and 15 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)Population: All enrolled participants who started treatment. Number of participants analyzed=number of evaluable participants for each laboratory parameter.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 urinalysis test abnormalities for urine protein.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=31 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=6 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities (Urinalysis)
|
2 participant
|
1 participant
|
1 participant
|
6 participant
|
4 participant
|
1 participant
|
3 participant
|
1 participant
|
15 participant
|
3 participant
|
0 participant
|
2 participant
|
5 participant
|
4 participant
|
1 participant
|
2 participant
|
0 participant
|
SECONDARY outcome
Timeframe: Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)Population: All enrolled participants who started treatment. N=number of participants evaluated against criteria.
Number of participants with vital signs values meeting prespecified criteria. Criteria defined as: 1) absolute systolic blood pressue (SBP) less than or equal to (\<=) 100 millimeter of mercury (mmHg); 2) absolute SBP greater than or equal to (\>=) 160 mmHg, 3) SBP maximum increase of \>=20 mmHg from baseline; 4) SBP maximum increase of \>=40 mmHg from baseline; 5) SBP maximum increase of \>=60 mmHg from baseline; 6) absolute diastolic blood pressure (DBP) \<=60 mmHg; 7) absolute DBP \>=100 mmHg; 8) DBP maximum increase of \>=10 mmHg from baseline; 9) DBP maximum increase of \>=20 mmHg from baseline; 10) DBP maximum increase of \>=30 mmHg from baseline; 11) absolute heart rate (HR) \<50 beats per minute (bpm); 12) absolute HR \>120 bpm.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=31 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)
|
1 participants
|
0 participants
|
0 participants
|
4 participants
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
9 participants
|
2 participants
|
2 participants
|
3 participants
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
4 participants
|
2 participants
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
7 participants
|
3 participants
|
1 participants
|
1 participants
|
3 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
3 participants
|
1 participants
|
2 participants
|
1 participants
|
14 participants
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
3 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1)
|
3 participants
|
0 participants
|
1 participants
|
4 participants
|
1 participants
|
1 participants
|
0 participants
|
3 participants
|
10 participants
|
1 participants
|
1 participants
|
2 participants
|
3 participants
|
0 participants
|
1 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1)
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.Population: Enrolled participants treated who had at least 1 of the pharmacokinetic (PK) parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=2 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=6 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=4 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=30 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C
Cycle 1 Day 2 (N=2, 6, 4, 30)
|
NA nanogram (ng)/milliliter (mL)
Geometric Coefficient of Variation NA
For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 1640 and 3050 ng/mL, respectively.
|
3404 nanogram (ng)/milliliter (mL)
Geometric Coefficient of Variation 82
|
4759 nanogram (ng)/milliliter (mL)
Geometric Coefficient of Variation 25
|
5221 nanogram (ng)/milliliter (mL)
Geometric Coefficient of Variation 61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C
Cycle 1 Day 16 (N=3, 6, 4, 28)
|
2201 nanogram (ng)/milliliter (mL)
Geometric Coefficient of Variation 16
|
2814 nanogram (ng)/milliliter (mL)
Geometric Coefficient of Variation 50
|
4656 nanogram (ng)/milliliter (mL)
Geometric Coefficient of Variation 32
|
5728 nanogram (ng)/milliliter (mL)
Geometric Coefficient of Variation 56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=4 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=6 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=2 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2)
|
3625 ng/mL
Geometric Coefficient of Variation 62
|
5937 ng/mL
Geometric Coefficient of Variation 32
|
11170 ng/mL
Geometric Coefficient of Variation 16
|
8476 ng/mL
Geometric Coefficient of Variation 32
|
8586 ng/mL
Geometric Coefficient of Variation 36
|
6279 ng/mL
Geometric Coefficient of Variation 70
|
7239 ng/mL
Geometric Coefficient of Variation 39
|
NA ng/mL
Geometric Coefficient of Variation NA
For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 9250 and 15200 ng/mL, respectively.
|
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Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1)
|
8621 ng/mL
Geometric Coefficient of Variation 18
|
6153 ng/mL
Geometric Coefficient of Variation 34
|
12440 ng/mL
Geometric Coefficient of Variation 32
|
8717 ng/mL
Geometric Coefficient of Variation 50
|
8913 ng/mL
Geometric Coefficient of Variation 54
|
9280 ng/mL
Geometric Coefficient of Variation NA
Individual value is reported. For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.
|
7989 ng/mL
Geometric Coefficient of Variation 45
|
15400 ng/mL
Geometric Coefficient of Variation NA
Individual value is reported. For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.
|
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SECONDARY outcome
Timeframe: Cycle 0 Day -1 and Cycle 1 Day 1: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=2 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D
Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2)
|
85.28 ng/mL
Geometric Coefficient of Variation 27
|
63.80 ng/mL
Geometric Coefficient of Variation 14
|
87.99 ng/mL
Geometric Coefficient of Variation 51
|
180.6 ng/mL
Geometric Coefficient of Variation 28
|
191.9 ng/mL
Geometric Coefficient of Variation 44
|
115.8 ng/mL
Geometric Coefficient of Variation 70
|
231.3 ng/mL
Geometric Coefficient of Variation 69
|
NA ng/mL
Geometric Coefficient of Variation NA
For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 204 and 372 ng/mL, respectively.
|
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—
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—
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—
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—
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—
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|
Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D
Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2)
|
91.69 ng/mL
Geometric Coefficient of Variation 31
|
74.23 ng/mL
Geometric Coefficient of Variation 43
|
64.99 ng/mL
Geometric Coefficient of Variation 56
|
138.7 ng/mL
Geometric Coefficient of Variation 23
|
183.6 ng/mL
Geometric Coefficient of Variation 29
|
114.6 ng/mL
Geometric Coefficient of Variation 50
|
211.9 ng/mL
Geometric Coefficient of Variation 44
|
NA ng/mL
Geometric Coefficient of Variation NA
For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 247 and 428 ng/mL, respectively.
|
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—
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SECONDARY outcome
Timeframe: Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Cycle 0 Day -7 (N=5, 1, 1)
|
304.9 ng/mL
Geometric Coefficient of Variation 49
|
280 ng/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
101 ng/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
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—
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Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Cycle 1 Day 12 (N=4, 1, 1)
|
341.9 ng/mL
Geometric Coefficient of Variation 21
|
690 ng/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
182 ng/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
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—
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—
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—
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SECONDARY outcome
Timeframe: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Cycle 0 Day -7 (N=5, 1, 1)
|
38.02 ng/mL
Geometric Coefficient of Variation 28
|
59.8 ng/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
48.7 ng/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
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Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Cycle 1 Day 12 (N=4, 1, 1)
|
52.02 ng/mL
Geometric Coefficient of Variation 13
|
21.2 ng/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
64.7 ng/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
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SECONDARY outcome
Timeframe: Cycle 0 Day -7 at 0 hours (pre-dose) and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6 8 and 24 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B
Cycle 0 Day -7 (N=7, 7)
|
41.44 ng/mL
Standard Deviation 8.1201 • Interval 1.0 to 8.0
|
68.41 ng/mL
Standard Deviation 31.818 • Interval 1.0 to 4.13
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Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B
Cycle 1 Day 12 (N=7, 5)
|
46.81 ng/mL
Standard Deviation 19.381 • Interval 1.0 to 4.0
|
87.30 ng/mL
Standard Deviation 37.647 • Interval 1.02 to 6.0
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SECONDARY outcome
Timeframe: Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=2 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=6 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=4 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=30 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C
Cycle 1 Day 2 (N=2, 6, 4, 30)
|
1.30 hour (hr)
Interval 1.0 to 1.6
|
1.02 hour (hr)
Interval 0.5 to 1.67
|
0.992 hour (hr)
Interval 0.5 to 1.0
|
0.500 hour (hr)
Interval 0.467 to 1.07
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Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C
Cycle 1 Day 16 (N=3, 6, 4, 28)
|
1.00 hour (hr)
Interval 1.0 to 1.08
|
0.992 hour (hr)
Interval 0.583 to 1.05
|
0.734 hour (hr)
Interval 0.5 to 1.0
|
0.525 hour (hr)
Interval 0.333 to 2.92
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SECONDARY outcome
Timeframe: Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=4 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=6 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=2 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2)
|
0.500 hr
Interval 0.5 to 1.0
|
0.500 hr
Interval 0.5 to 0.983
|
0.500 hr
Interval 0.5 to 0.5
|
0.500 hr
Interval 0.5 to 3.22
|
0.509 hr
Interval 0.5 to 0.583
|
1.00 hr
Interval 0.5 to 3.08
|
0.500 hr
Interval 0.5 to 0.6
|
0.500 hr
Interval 0.5 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1)
|
0.500 hr
Interval 0.5 to 0.5
|
0.500 hr
Interval 0.5 to 1.0
|
0.500 hr
Interval 0.5 to 0.517
|
0.509 hr
Interval 0.5 to 0.567
|
0.517 hr
Interval 0.5 to 0.583
|
0.667 hr
Interval 0.667 to 0.667
|
0.500 hr
Interval 0.5 to 3.92
|
0.500 hr
Interval 0.5 to 0.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 0 Day -1 and Cycle 1 Day 1: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=2 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D
Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2)
|
1.00 hr
Interval 1.0 to 6.02
|
2.00 hr
Interval 2.0 to 3.0
|
1.03 hr
Interval 1.0 to 2.33
|
1.97 hr
Interval 0.917 to 4.0
|
1.07 hr
Interval 1.0 to 2.0
|
1.00 hr
Interval 0.333 to 4.0
|
2.00 hr
Interval 1.0 to 4.0
|
2.50 hr
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D
Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2)
|
1.00 hr
Interval 1.0 to 2.0
|
2.00 hr
Interval 1.0 to 4.0
|
1.00 hr
Interval 1.0 to 4.0
|
2.00 hr
Interval 1.0 to 4.0
|
1.00 hr
Interval 1.0 to 2.02
|
2.00 hr
Interval 2.0 to 4.05
|
1.50 hr
Interval 1.0 to 6.0
|
1.00 hr
Interval 1.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Cycle 0 Day -7 (N=5, 1, 1)
|
1.00 hr
Interval 1.0 to 4.0
|
2.00 hr
Interval 2.0 to 2.0
|
1.92 hr
Interval 1.92 to 1.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Cycle 1 Day 12 (N=4, 1, 1)
|
1.00 hr
Interval 1.0 to 1.02
|
1.00 hr
Interval 1.0 to 1.0
|
4.00 hr
Interval 4.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Cycle 0 Day -7 (N=5, 1, 1)
|
1.00 hr
Interval 1.0 to 6.0
|
1.00 hr
Interval 1.0 to 1.0
|
1.90 hr
Interval 1.9 to 1.9
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Cycle 1 Day 12 (N=4, 1, 1)
|
2.00 hr
Interval 1.02 to 2.0
|
0.00 hr
Interval 0.0 to 0.0
|
2.00 hr
Interval 2.0 to 2.0
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Cycle 0 Day -7 at 0 hours (pre-dose) and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6 8 and 24 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B
Cycle 0 Day -7 (N=7, 7)
|
2 hr
Interval 1.0 to 8.0
|
1.07 hr
Interval 1.0 to 4.13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B
Cycle 1 Day 12 (N=7, 5)
|
2 hr
Interval 1.0 to 4.0
|
2.03 hr
Interval 1.02 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=25 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C
Cycle 1 Day 2 (N=1, 5, 3, 25)
|
24.5 hr
Standard Deviation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
32.14 hr
Standard Deviation 1.3334
|
29.23 hr
Standard Deviation 7.1066
|
32.16 hr
Standard Deviation 4.5154
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
|
Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C
Cycle 1 Day 16 (N=1, 5, 3, 20)
|
33.3 hr
Standard Deviation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
37.98 hr
Standard Deviation 5.5603
|
34.50 hr
Standard Deviation 8.4256
|
35.10 hr
Standard Deviation 3.3067
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=6 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=6 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=2 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2)
|
24.62 hr
Standard Deviation 3.2306
|
27.37 hr
Standard Deviation 6.4748
|
30.77 hr
Standard Deviation 6.4933
|
25.85 hr
Standard Deviation 4.1530
|
29.35 hr
Standard Deviation 5.5121
|
29.63 hr
Standard Deviation 3.7072
|
27.05 hr
Standard Deviation 4.6651
|
NA hr
Standard Deviation NA
For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 24.6 and 24.8 hr, respectively.
|
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Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1)
|
35.90 hr
Standard Deviation 4.8816
|
39.30 hr
Standard Deviation 10.678
|
41.25 hr
Standard Deviation 6.2303
|
34.43 hr
Standard Deviation 8.5383
|
40.20 hr
Standard Deviation 5.8643
|
37.0 hr
Standard Deviation NA
Individual value is reported. For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.
|
33.30 hr
Standard Deviation 0.96437
|
37.0 hr
Standard Deviation NA
Individual value is reported. For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.
|
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SECONDARY outcome
Timeframe: Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.Population: Enrolled participants treated who had at least 1 of the pharmacokinetic (PK) parameters of interest estimated.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half Life (t½) for PD-0325901 on Cycle 0 Day -7 for Arm A
|
13.92 hr
Standard Deviation 4.2260
|
18.3 hr
Standard Deviation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
25.7 hr
Standard Deviation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
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SECONDARY outcome
Timeframe: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Cycle 0 Day -7 (N=5, 1, 1)
|
9.374 hr
Standard Deviation 1.3243
|
12.4 hr
Standard Deviation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
11.5 hr
Standard Deviation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
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Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Cycle 1 Day 12 (N=4, 0, 0)
|
8.968 hr
Standard Deviation 1.5366
|
NA hr
Standard Deviation NA
N = 0.
|
NA hr
Standard Deviation NA
N = 0.
|
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SECONDARY outcome
Timeframe: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=6 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B
Cycle 0 Day -7 (N=6, 7)
|
13.13 hr
Standard Deviation 2.2879
|
13.06 hr
Standard Deviation 2.6589
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Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B
Cycle 1 Day 12 (N=3, 1)
|
8.597 hr
Standard Deviation 1.2726
|
8.97 hr
Standard Deviation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
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SECONDARY outcome
Timeframe: Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=6 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=4 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=31 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C
Cycle 1 Day 2 (N=2, 6, 4, 30)
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 7410 and 10500 ng\*hr/mL, respectively.
|
7487 ng*hr/mL
Geometric Coefficient of Variation 41
|
10530 ng*hr/mL
Geometric Coefficient of Variation 44
|
9485 ng*hr/mL
Geometric Coefficient of Variation 43
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C
Cycle 1 Day 16 (N=3, 6, 4, 28)
|
8819 ng*hr/mL
Geometric Coefficient of Variation 71
|
8243 ng*hr/mL
Geometric Coefficient of Variation 25
|
11170 ng*hr/mL
Geometric Coefficient of Variation 53
|
10890 ng*hr/mL
Geometric Coefficient of Variation 38
|
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SECONDARY outcome
Timeframe: Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=4 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=2 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2)
|
7627 ng*hr/mL
Geometric Coefficient of Variation 46
|
10250 ng*hr/mL
Geometric Coefficient of Variation 21
|
14850 ng*hr/mL
Geometric Coefficient of Variation 31
|
12590 ng*hr/mL
Geometric Coefficient of Variation 27
|
14280 ng*hr/mL
Geometric Coefficient of Variation 24
|
13840 ng*hr/mL
Geometric Coefficient of Variation 47
|
9619 ng*hr/mL
Geometric Coefficient of Variation 22
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 14900 and 18800 ng\*hr/mL, respectively.
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1)
|
12070 ng*hr/mL
Geometric Coefficient of Variation 36
|
12130 ng*hr/mL
Geometric Coefficient of Variation 1
|
19970 ng*hr/mL
Geometric Coefficient of Variation 25
|
13390 ng*hr/mL
Geometric Coefficient of Variation 21
|
21170 ng*hr/mL
Geometric Coefficient of Variation 36
|
15200 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.
|
12610 ng*hr/mL
Geometric Coefficient of Variation 25
|
20800 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.
|
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SECONDARY outcome
Timeframe: Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
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PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
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PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
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PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
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PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PD-0325901 on Cycle 0 Day -7 for Arm A
|
1479 ng*hr/mL
Geometric Coefficient of Variation 23
|
2030 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
941 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
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SECONDARY outcome
Timeframe: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
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PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
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PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
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PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
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PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
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PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm A
|
474.5 ng*hr/mL
Geometric Coefficient of Variation 29
|
933 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
688 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
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SECONDARY outcome
Timeframe: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
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PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm B
|
588.4 ng*hr/mL
Geometric Coefficient of Variation 49
|
1001 ng*hr/mL
Geometric Coefficient of Variation 35
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SECONDARY outcome
Timeframe: Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=6 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=4 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=31 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C
Cycle 1 Day 2 (N=1, 5, 3, 25)
|
7540 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
7968 ng*hr/mL
Geometric Coefficient of Variation 41
|
9277 ng*hr/mL
Geometric Coefficient of Variation 48
|
10070 ng*hr/mL
Geometric Coefficient of Variation 42
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C
Cycle 1 Day 16 (N=1, 5, 3, 20)
|
5870 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
8627 ng*hr/mL
Geometric Coefficient of Variation 26
|
9174 ng*hr/mL
Geometric Coefficient of Variation 17
|
10610 ng*hr/mL
Geometric Coefficient of Variation 37
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SECONDARY outcome
Timeframe: Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=3 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=4 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=2 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2)
|
6353 ng*hr/mL
Geometric Coefficient of Variation 40
|
10460 ng*hr/mL
Geometric Coefficient of Variation 20
|
14880 ng*hr/mL
Geometric Coefficient of Variation 39
|
12600 ng*hr/mL
Geometric Coefficient of Variation 29
|
14620 ng*hr/mL
Geometric Coefficient of Variation 23
|
14230 ng*hr/mL
Geometric Coefficient of Variation 46
|
9766 ng*hr/mL
Geometric Coefficient of Variation 22
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP. Individual values of these 2 participants were 15100 and 19100 ng\*hr/mL, respectively.
|
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1)
|
10430 ng*hr/mL
Geometric Coefficient of Variation 33
|
12460 ng*hr/mL
Geometric Coefficient of Variation 2
|
20440 ng*hr/mL
Geometric Coefficient of Variation 26
|
13770 ng*hr/mL
Geometric Coefficient of Variation 20
|
23730 ng*hr/mL
Geometric Coefficient of Variation 39
|
15500 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.
|
13320 ng*hr/mL
Geometric Coefficient of Variation 27
|
21300 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. For arms with \<3 participants with reportable values, data summary statistics were not calculated per standard practice and as specified in the SAP.
|
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SECONDARY outcome
Timeframe: Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PD-0325901 on Cycle 0 Day -7 for Arm A
|
1599 ng*hr/mL
Geometric Coefficient of Variation 26
|
2140 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
1060 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
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SECONDARY outcome
Timeframe: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm A
|
523.9 ng*hr/mL
Geometric Coefficient of Variation 21
|
950 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
697 ng*hr/mL
Geometric Coefficient of Variation NA
Individual value is reported. Summary statistics are not presented if fewer than 3 subjects have reportable parameter values.
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=6 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm B
|
705.0 ng*hr/mL
Geometric Coefficient of Variation 41
|
1028 ng*hr/mL
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 2 for Arms C and D, Cycle 1 Day 15 for Arm D, and Cycle 1 Day 16 for Arm C, Day 2 in Arm C and Day 1 in Arm D for subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)Population: All participants enrolled in the study having at least one ECG assessment after receiving study drug for the respective arm.
Electrocardiogram (ECG) measurements (an average of the triplicate measurements) were used for the statistical analysis and all data presentations. QT intervals were corrected for heart rate (QTc) using Bazett's Formula (QTcB) and Fridericia's Formula (QTcF) .
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=30 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=5 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Increase From Baseline in QT Interval
Maximum QTcB Interval Increase <30msec
|
4 participants
|
0 participants
|
1 participants
|
7 participants
|
7 participants
|
2 participants
|
5 participants
|
4 participants
|
28 participants
|
7 participants
|
2 participants
|
2 participants
|
6 participants
|
4 participants
|
3 participants
|
3 participants
|
2 participants
|
|
Number of Participants With Increase From Baseline in QT Interval
MaximumQTcB Interval Increase >=30to<60msec
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Increase From Baseline in QT Interval
Maximum QTcB Interval Increase >=60 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Increase From Baseline in QT Interval
MaximumQTcF Interval Increase >=30 to<60msec
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
6 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Increase From Baseline in QT Interval
Maximum QTcF Interval Increase >=60 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Increase From Baseline in QT Interval
Maximum QTcF Interval Increase <30 msec
|
5 participants
|
0 participants
|
1 participants
|
7 participants
|
5 participants
|
2 participants
|
5 participants
|
3 participants
|
24 participants
|
6 participants
|
3 participants
|
2 participants
|
6 participants
|
5 participants
|
3 participants
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 2 for Arms C and D, Cycle 1 Day 15 for Arm D, and Cycle 1 Day 16 for Arm C, Day 2 in Arm C and Day 1 in Arm D for subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)Population: All participants enrolled in the study having at least one ECG assessment after receiving study drug for the respective arm.
Electrocardiogram (ECG) measurements (an average of the triplicate measurements) were used for the statistical analysis and all data presentations. QT intervals were corrected for heart rate (QTc) using Bazett's Formula (QTcB) and Fridericia's Formula (QTcF).
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=31 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Post-dose QT Interval Corrected
Maximum QTcB Interval <450 msec
|
2 participants
|
0 participants
|
1 participants
|
4 participants
|
3 participants
|
2 participants
|
4 participants
|
1 participants
|
22 participants
|
2 participants
|
3 participants
|
3 participants
|
2 participants
|
4 participants
|
3 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Maximum Post-dose QT Interval Corrected
Maximum QTcB Interval 450 to <=480 msec
|
3 participants
|
0 participants
|
0 participants
|
3 participants
|
4 participants
|
1 participants
|
2 participants
|
3 participants
|
5 participants
|
5 participants
|
0 participants
|
1 participants
|
5 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Maximum Post-dose QT Interval Corrected
Maximum QTcB Interval >480 to <=500 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Maximum Post-dose QT Interval Corrected
Maximum QTcB Interval >500 msec
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Maximum Post-dose QT Interval Corrected
Maximum QTcF Interval <450 msec
|
4 participants
|
0 participants
|
1 participants
|
7 participants
|
3 participants
|
3 participants
|
6 participants
|
2 participants
|
24 participants
|
6 participants
|
3 participants
|
4 participants
|
6 participants
|
5 participants
|
3 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Maximum Post-dose QT Interval Corrected
Maximum QTcF Interval 450 to <=480 msec
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
0 participants
|
0 participants
|
2 participants
|
5 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Maximum Post-dose QT Interval Corrected
Maximum QTcF Interval >480 to <=500 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Maximum Post-dose QT Interval Corrected
Maximum QTcF Interval >500 msec
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until progression of disease was documented.Population: All participants who started treatment on the assigned arm and had an adequate baseline tumor assessment.
CR was defined as the disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=6 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=30 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 60.2
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
0 percentage of participants
Interval 0.0 to 41.0
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
0 percentage of participants
Interval 0.0 to 70.8
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 60.2
|
0 percentage of participants
Interval 0.0 to 84.2
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until progression of disease was documented.Population: All participants who started treatment on the assigned arm and had an adequate baseline tumor assessment.
Progression-free survival (PFS) was the time from first dose to date of first documentation of progression or death due to any cause.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=30 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) (Stage 2)
|
2.8 months
Interval 1.7 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)Population: All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=2 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=3 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=25 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=5 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=6 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=5 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=1 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D
|
0.974 ratio
Standard Deviation 0.0864
|
1.015 ratio
Standard Deviation 0.1935
|
NA ratio
Standard Deviation NA
Arm C1 for Stage 1 had 2 participants with data at End of treatment and were not summarized. The individual values were 1.305 and 1.293.
|
1.011 ratio
Standard Deviation 0.1165
|
NA ratio
Standard Deviation NA
Arm C3 for Stage 1 had 3 participants with data at End of treatment and were not summarized. The individual values were 0.64, 1.262, and 1.093.
|
1.111 ratio
Standard Deviation 0.2895
|
1.212 ratio
Standard Deviation 0.3284
|
NA ratio
Standard Deviation NA
Arm D0A for Stage 1 had 3 participants with data at End of treatment and were not summarized. The individual values were 0.708 , 0.973 and 1.024.
|
NA ratio
Standard Deviation NA
Arm D0B for Stage 1 had 2 participants with data at End of treatment and were not summarized. The individual values were 0.956 and 1.104.
|
0.966 ratio
Standard Deviation 0.1904
|
1.13 ratio
Standard Deviation 0.3886
|
NA ratio
Standard Deviation NA
Arm D1B for Stage 1 had 3 participants with data at End of treatment and were not summarized. The individual values were 1.641,1.198 and 0.947.
|
NA ratio
Standard Deviation NA
Arm D2 for Stage 1 had 4 participants with data at End of treatment and were not summarized. The individual values were 0.93, 0.74, 1.113 and 0.817.
|
NA ratio
Standard Deviation NA
Arm D2A for Stage 1 had 1 participants with data at End of treatment and were not summarized. The individual values was 0.783.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)Population: All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=4 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=6 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=2 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=3 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=22 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=1 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=5 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=1 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D
|
NA ratio
Standard Deviation NA
Arm B1 for Stage 1 had 4 participants with data at End of treatment and were not summarized. The individual values were 0.412, 2.2, 1, 0.973.
|
1.628 ratio
Standard Deviation 1.888
|
NA ratio
Standard Deviation NA
Arm C1 for Stage 1 had 2 participants with data at End of treatment and were not summarized. The individual values were 1.528 and 1.14.
|
2.178 ratio
Standard Deviation 2.3194
|
NA ratio
Standard Deviation NA
Arm C3 for Stage 1 had 3 participants with data at End of treatment and were not summarized. The individual values were 0.244, 0.769, 0.552.
|
1.699 ratio
Standard Deviation 2.0031
|
NA ratio
Standard Deviation NA
Arm D0 for Stage 1 had 4 participants with data at End of treatment and were not summarized. The individual values were 0.833, 5.143, 0.979, 0.744.
|
NA ratio
Standard Deviation NA
Arm D0A for Stage 1 had 3 participants with data at End of treatment and were not summarized. The individual values were 0.374, 0.905, 0.736.
|
NA ratio
Standard Deviation NA
Arm D0B for Stage 1 had 1 participant with data at End of treatment and was not summarized. The individual value was 1.434.
|
2.233 ratio
Standard Deviation 2.3617
|
NA ratio
Standard Deviation NA
Arm D1A for Stage 1 had 4 participants with data at End of treatment and were not summarized. The individual values were2.026, 0.665, 0.32, 4.404.
|
NA ratio
Standard Deviation NA
Arm D1B for Stage 1 had 3 participants with data at End of treatment and were not summarized. The individual values were 2.116, 1.187, 1.172.
|
NA ratio
Standard Deviation NA
Arm D2 for Stage 1 had 4 participants with data at End of treatment and were not summarized. The individual values were 0.403, 0.281, 3.293, 3.776.
|
NA ratio
Standard Deviation NA
Arm D2A for Stage 1 had 1 participant with data at End of treatment and was not summarized. The individual value was 0.083.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)Population: All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ratio to Baseline in Serum Glucose Level at Cycle 2 Day 16 for Arm A
|
0.965 ratio
Standard Deviation 0.2697
|
NA ratio
Standard Deviation NA
Arm A2 for Stage 1 had only 1 participant with data at Cycle 2 Day 16 and was not summarized. The individual value for the 1 participant was 1.035.
|
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|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)Population: All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ratio to Baseline in Serum Insulin Level at Cycle 2 Day 16 for Arm A
|
0.652 ratio
Standard Deviation 0.3622
|
NA ratio
Standard Deviation NA
Arm A2 for Stage 1 had only 1 participant with data at Cycle 2 Day 16 and was not summarized. The individual value for the 1 participant was 0.972.
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
|
—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 1 Day 23.Population: All enrolled participants who started treatment and had baseline tumor tissues successfully analyzed for at least one of the biomarkers.
Number of participants with expression of genes relating to PI3K, MAPK and/or Wnt pathway signaling (kirsten rat sarcoma 2 viral oncogene homolog \[KRAS\] and PTEN protein). Biopsies were obtained at baseline and Cycle 1 Day 23. Biomarker evaluation was performed on these biopsies.
Outcome measures
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 Participants
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=6 Participants
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 Participants
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 Participants
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=5 Participants
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 Participants
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=24 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0A (Stage 1)
n=4 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=6 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D1B (Stage 1)
n=7 Participants
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D2 (Stage 1)
n=3 Participants
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=1 Participants
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling
KRAS mutation
|
4 participants
|
1 participants
|
1 participants
|
0 participants
|
3 participants
|
0 participants
|
2 participants
|
1 participants
|
10 participants
|
2 participants
|
1 participants
|
2 participants
|
4 participants
|
6 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling
PTEN tumor manual score
|
4 participants
|
1 participants
|
1 participants
|
5 participants
|
6 participants
|
3 participants
|
5 participants
|
4 participants
|
24 participants
|
4 participants
|
2 participants
|
3 participants
|
6 participants
|
7 participants
|
2 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling
PTEN stroma manual score
|
4 participants
|
1 participants
|
1 participants
|
5 participants
|
6 participants
|
3 participants
|
4 participants
|
4 participants
|
24 participants
|
4 participants
|
2 participants
|
3 participants
|
6 participants
|
7 participants
|
2 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until until progression of disease was documented.Population: There was only 1 participant in Arm C1 and 1 in Arm C2 with a response, therefore summary statistics were not calculated for this endpoint.
Duration of response was to be calculated for participants with an objective response. Duration of PR or CR was the time from start date (date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.
Outcome measures
Outcome data not reported
Adverse Events
PF-04691502+PF-0325901: Arm A1 (Stage1)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-04691502+PF 0325901: Arm A2 (Stage1)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-04691502+PF 0325901: Arm A4 (Stage1)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-04691502+Irinotecan: Arm B1 (Stage 1)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-04691502+Irinotecan: Arm B2 (Stage 1)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-05212384+Irinotecan: Arm C1 (Stage 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-05212384+Irinotecan: Arm C2 (Stage 1)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-05212384+Irinotecan: Arm C3 (Stage 1)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-05212384+Irinotecan: Arm C2 (Stage 2)
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-05212384+PD-0325901: Arm D0A (Stage 1)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-05212384+ PD-0325901: Arm D1B (Stage 1))
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-05212384+ PD-0325901: Arm D2 (Stage 1)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 participants at risk
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 participants at risk
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 participants at risk
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 participants at risk
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 participants at risk
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 participants at risk
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 participants at risk
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 participants at risk
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 2)
n=31 participants at risk
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=7 participants at risk
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D0A (Stage 1)
n=3 participants at risk
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=4 participants at risk
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=7 participants at risk
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 participants at risk
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1B (Stage 1))
n=3 participants at risk
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2 (Stage 1)
n=4 participants at risk
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 participants at risk
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Fatigue
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Anal abscess
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Lung infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Transaminases increased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Asthenia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Device related infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Disease progression
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Skin infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Mucosal inflammation
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
Other adverse events
| Measure |
PF-04691502+PF-0325901: Arm A1 (Stage1)
n=5 participants at risk
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A2 (Stage1)
n=1 participants at risk
Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+PF 0325901: Arm A4 (Stage1)
n=1 participants at risk
Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-04691502+Irinotecan: Arm B1 (Stage 1)
n=7 participants at risk
Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-04691502+Irinotecan: Arm B2 (Stage 1)
n=7 participants at risk
Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C1 (Stage 1)
n=3 participants at risk
Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 1)
n=6 participants at risk
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C3 (Stage 1)
n=4 participants at risk
Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly.
|
PF-05212384+Irinotecan: Arm C2 (Stage 2)
n=31 participants at risk
Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled.
|
PF-05212384+ PD-0325901: Arm D0 (Stage 1)
n=7 participants at risk
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+PD-0325901: Arm D0A (Stage 1)
n=3 participants at risk
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D0B (Stage 1)
n=4 participants at risk
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1 (Stage 1)
n=7 participants at risk
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1A (Stage 1)
n=7 participants at risk
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D1B (Stage 1))
n=3 participants at risk
Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2 (Stage 1)
n=4 participants at risk
Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
PF-05212384+ PD-0325901: Arm D2A (Stage 1)
n=2 participants at risk
Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Tremor
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
38.7%
12/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
2/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
22.6%
7/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
75.0%
3/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
1/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Joint abscess
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
60.0%
3/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
3/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
9.7%
3/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
1/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.0%
2/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
22.6%
7/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
75.0%
3/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
2/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
12.9%
4/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
22.6%
7/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
2/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
5/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
2/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
75.0%
3/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
54.8%
17/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
2/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
71.4%
5/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
1/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
71.4%
5/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
71.4%
5/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
3/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
3/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
2/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
61.3%
19/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
66.7%
2/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
71.4%
5/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
1/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
19.4%
6/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
57.1%
4/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
66.7%
2/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
85.7%
6/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
57.1%
4/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
3/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
2/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
45.2%
14/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
2/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
71.4%
5/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Asthenia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
32.3%
10/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
66.7%
2/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
2/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
2/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Fatigue
|
60.0%
3/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
66.7%
2/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
2/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
2/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
29.0%
9/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
57.1%
4/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
71.4%
5/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Pain
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
2/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
19.4%
6/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Urinary tract infection
|
40.0%
2/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.1%
5/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
9.7%
3/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
66.7%
2/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
57.1%
4/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
57.1%
4/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
66.7%
2/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
75.0%
3/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
38.7%
12/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
12.9%
4/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
1/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
9.7%
3/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.1%
5/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.1%
5/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
75.0%
3/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Weight decreased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
9.7%
3/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.1%
5/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
19.4%
6/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
12.9%
4/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
1/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
2/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
22.6%
7/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Photophobia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Oral pain
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
9.7%
3/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Catheter site rash
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Mucosal inflammation
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
66.7%
2/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.1%
5/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
57.1%
4/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
2/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Device related infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Gingivitis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.1%
5/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
9.7%
3/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
2/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
7.7%
1/13 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
2/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
9.7%
3/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
66.7%
2/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
6.5%
2/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
40.0%
2/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
16.7%
1/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
66.7%
2/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
57.1%
4/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
66.7%
2/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Nail bed disorder
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
2/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
2/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Vascular disorders
Flushing
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
66.7%
2/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
3.2%
1/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Ear and labyrinth disorders
Ear pain
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Dry eye
|
40.0%
2/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Iridocyclitis
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Retinal detachment
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Vision blurred
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Visual acuity reduced
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Eye pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Retinopathy
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Eye disorders
Visual impairment
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
40.0%
2/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Odynophagia
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Proctalgia
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Catheter site inflammation
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Catheter site ulcer
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Chest pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Chills
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Disease progression
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Early satiety
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Injection site mass
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Malaise
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
General disorders
Thirst
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Immune system disorders
Seasonal allergy
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Anal infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Candida infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Oral candidiasis
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Skin infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Blood calcium increased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Blood iron decreased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Investigations
Troponin T increased
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Fluid retention
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
1/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Fistula discharge
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Psychiatric disorders
Confusional state
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Psychiatric disorders
Hallucination
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
42.9%
3/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Renal and urinary disorders
Choluria
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
100.0%
1/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Reproductive system and breast disorders
Ejaculation failure
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
28.6%
2/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
1/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
50.0%
2/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
66.7%
2/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Vascular disorders
Embolism
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Vascular disorders
Hot flush
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Vascular disorders
Lymphoedema
|
20.0%
1/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Vascular disorders
Pallor
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
25.0%
1/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/1 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/6 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/31 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
33.3%
1/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
14.3%
1/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/7 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/3 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/4 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
0.00%
0/2 • Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER