Trial Outcomes & Findings for A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC) (NCT NCT01920061)
NCT ID: NCT01920061
Last Updated: 2022-09-13
Results Overview
DLT was defined as any of the following adverse events (AEs) attributable to the combination: (1) hematologic: grade 4 neutropenia lasting \>7 days; febrile neutropenia; grade \>=3 neutropenia with infection; grade 3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade \>=2 pneumonitis; grade\>=3 toxicities, except pneumonitis, and excluding those that had not been maximally treated; persistent, intolerable toxicities which resulted in the failure to deliver at least 3 of the 4 doses of PF-05212384 for Arms A and B or at least 3 of the 4 doses of PF-05212384 and 75% of dacomitinib for Arm C during the first cycle; the persistent, intolerable toxicities which result in delay of the start of the second cycle by more than 2 weeks relative to the scheduled start; in an asymptomatic participant, the grade 3 QTc prolongation persists after correction of any reversible causes.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
110 participants
Primary outcome timeframe
Up to 21 days
Results posted on
2022-09-13
Participant Flow
Arm A included 5 sub-arms: Arms A1, A2, A3, A4, A5 Arm B included 8 sub-arms: Arms B1, B2, B3, B4, B5, B6, B7, B8 Arm C included 5 sub-arms: Arms C1, C1h, C2, C3, C4 Arm B Expansion included 2 sub-arms: Arms 1, 2
A total of 110 subjets were enrolled in this study and 3 of them didn't received any study treatment.
Participant milestones
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastatic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Overall Study
STARTED
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4
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5
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3
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4
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5
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4
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3
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3
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3
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3
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10
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5
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3
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16
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4
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7
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3
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3
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10
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12
|
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Overall Study
Received Treatment
|
4
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5
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3
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3
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5
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4
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3
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3
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3
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3
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10
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5
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2
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15
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4
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7
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3
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3
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10
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12
|
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Overall Study
COMPLETED
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2
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1
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1
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2
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3
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2
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2
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2
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2
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1
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5
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2
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1
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10
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3
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4
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1
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1
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4
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8
|
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Overall Study
NOT COMPLETED
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2
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4
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2
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2
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2
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2
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1
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1
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1
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2
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5
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3
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2
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6
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1
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3
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2
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2
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6
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4
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Reasons for withdrawal
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastatic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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|
Overall Study
Death
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1
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1
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0
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1
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1
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0
|
0
|
1
|
0
|
1
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0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
1
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0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
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0
|
0
|
0
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0
|
1
|
0
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0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
3
|
|
Overall Study
Other
|
1
|
1
|
2
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
2
|
1
|
4
|
0
|
1
|
1
|
0
|
1
|
1
|
|
Overall Study
Participant refused further follow-up
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
1
|
2
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)
Baseline characteristics by cohort
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib
n=15 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastatic
n=10 Participants
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
n=12 Participants
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
9 Participants
n=17 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
14 Participants
n=8 Participants
|
3 Participants
n=16 Participants
|
7 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
9 Participants
n=667 Participants
|
11 Participants
n=7 Participants
|
97 Participants
n=6 Participants
|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 15.9 • n=4 Participants
|
63.6 years
STANDARD_DEVIATION 8.1 • n=21 Participants
|
57.3 years
STANDARD_DEVIATION 9.1 • n=10 Participants
|
51.7 years
STANDARD_DEVIATION 13.6 • n=115 Participants
|
54.7 years
STANDARD_DEVIATION 15.9 • n=6 Participants
|
54.0 years
STANDARD_DEVIATION 9.6 • n=6 Participants
|
55.7 years
STANDARD_DEVIATION 8.5 • n=64 Participants
|
54.6 years
STANDARD_DEVIATION 11.1 • n=17 Participants
|
58.2 years
STANDARD_DEVIATION 13.7 • n=21 Participants
|
59.5 years
STANDARD_DEVIATION 13.4 • n=22 Participants
|
53.4 years
STANDARD_DEVIATION 14.1 • n=8 Participants
|
54.3 years
STANDARD_DEVIATION 22.1 • n=16 Participants
|
55.4 years
STANDARD_DEVIATION 8.8 • n=135 Participants
|
49.7 years
STANDARD_DEVIATION 6.4 • n=136 Participants
|
56.3 years
STANDARD_DEVIATION 12.4 • n=44 Participants
|
52.4 years
STANDARD_DEVIATION 13.6 • n=667 Participants
|
54.8 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 10.7 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
10 Participants
n=17 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
8 Participants
n=8 Participants
|
4 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
10 Participants
n=667 Participants
|
12 Participants
n=7 Participants
|
73 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
7 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
7 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
34 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: The per protocol analysis set included all enrolled participants who received at least one dose of study medication and who did not receive less than 75% or more than 125% of the planned Cycle 1 dose of either study drug in the combination.
DLT was defined as any of the following adverse events (AEs) attributable to the combination: (1) hematologic: grade 4 neutropenia lasting \>7 days; febrile neutropenia; grade \>=3 neutropenia with infection; grade 3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade \>=2 pneumonitis; grade\>=3 toxicities, except pneumonitis, and excluding those that had not been maximally treated; persistent, intolerable toxicities which resulted in the failure to deliver at least 3 of the 4 doses of PF-05212384 for Arms A and B or at least 3 of the 4 doses of PF-05212384 and 75% of dacomitinib for Arm C during the first cycle; the persistent, intolerable toxicities which result in delay of the start of the second cycle by more than 2 weeks relative to the scheduled start; in an asymptomatic participant, the grade 3 QTc prolongation persists after correction of any reversible causes.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=8 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=13 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=2 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=2 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) - Arms A, B and C
With DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLTs) - Arms A, B and C
No DLT
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
3 Participants
|
0 Participants
|
13 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Dose Limiting Toxicities (DLTs) - Arms A, B and C
Data missing
|
0 Participants
|
0 Participants
|
1 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
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 up to 18 monthsPopulation: The response analysis set included all participants who received at least one dose of study medication, had the disease under study, and who had an adequate baseline tumor assessment.
Percentage of participants with objective response based on the assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm) and no new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=10 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=12 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response - Arm B Expansion
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
—
|
—
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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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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.Population: The safety analysis set included all enrolled participants who received at least one dose of study medication.
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Treatment Emergent AEs were those occurred for the first time after the start of study treatment and within 28 days after final dose of study treatment and was not seen prior to the start of treatment, or those were seen prior to the start of study treatment but increased in Common Terminology Criteria for Adverse Events (CTCAE) grade after the start of study treatment and within 28 days after final dose of study treatment. AEs were graded by the investigator according to the CTCAE version 4.03 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=15 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
n=10 Participants
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
n=12 Participants
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (All Causality) - Arms A, B, C and B Expansion
Grade 2 AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (All Causality) - Arms A, B, C and B Expansion
Grade 3 AEs
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (All Causality) - Arms A, B, C and B Expansion
Grade 4 AEs
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (All Causality) - Arms A, B, C and B Expansion
Grade 5 AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (All Causality) - Arms A, B, C and B Expansion
Grade 1 AEs
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.Population: The safety analysis set included all enrolled participants who received at least one dose of study medication.
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Treatment Emergent AEs were those occurred for the first time after the start of study treatment and within 28 days after final dose of study treatment and was not seen prior to the start of treatment, or those were seen prior to the start of study treatment but increased in Common Terminology Criteria for Adverse Events (CTCAE) grade after the start of study treatment and within 28 days after final dose of study treatment. AEs were graded by the investigator according to the CTCAE version 4.03 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=15 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
n=10 Participants
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
n=12 Participants
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) - Arms A, B, C and B Expansion
Grade 1 AEs
|
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
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) - Arms A, B, C and B Expansion
Grade 2 AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) - Arms A, B, C and B Expansion
Grade 4 AEs
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) - Arms A, B, C and B Expansion
Grade 3 AEs
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) - Arms A, B, C and B Expansion
Grade 5 AEs
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.Population: The safety analysis set included all enrolled participants who received at least one dose of study medication.
Laboratory abnormalities were graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Following parameters were analyzed for laboratory examination: anemia,hemoglobin increased, platelets, white blood cells, absolute neutrophils,lymphocyte count increased, lymphopenia.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=15 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
n=10 Participants
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
n=12 Participants
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Platelets · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Hemoglobin increased · Grade 0
|
4 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
12 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Hemoglobin increased · Grade 3
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Lymphopenia · Grade 1
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Hemoglobin increased · Grade 1
|
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
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Hemoglobin increased · Grade 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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Hemoglobin increased · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Lymphocyte count increased · Grade 1
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Lymphocyte count increased · Grade 2
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Lymphocyte count increased · Grade 3
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Lymphocyte count increased · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Lymphopenia · Grade 2
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Lymphopenia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Absolute neutrophils · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Absolute neutrophils · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Platelets · Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
White blood cells · Grade 0
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
10 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
White blood cells · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Platelets · Grade 1
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Lymphopenia · Grade 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Lymphopenia · Grade 3
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Absolute neutrophils · Grade 0
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
14 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Absolute neutrophils · Grade 3
|
2 Participants
|
1 Participants
|
1 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
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Absolute neutrophils · Grade 4
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Platelets · Grade 0
|
1 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
15 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Platelets · Grade 4
|
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
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
White blood cells · Grade 2
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
White blood cells · Grade 3
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
White blood cells · Grade 4
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 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 Laboratory Abnormalities by Severity (All Cycles) - Hematology
Anemia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Anemia · Grade 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Anemia · Grade 1
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Anemia · Grade 2
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Anemia · Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Hematology
Lymphocyte count increased · Grade 0
|
4 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.Population: The safety analysis set included all enrolled participants who received at least one dose of study medication.
Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Following parameters were analyzed for laboratory examination: partial thromboplastin time and prothrombin time international normalized ratio(INR).
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=15 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
n=10 Participants
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
n=12 Participants
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Coagulation
Partial thromboplastin time · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Coagulation
Prothrombin time INR · Grade 0
|
1 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
2 Participants
|
13 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Coagulation
Prothrombin time INR · Grade 1
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Coagulation
Prothrombin time INR · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Coagulation
Partial thromboplastin time · Grade 0
|
4 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
9 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Coagulation
Partial thromboplastin time · Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Coagulation
Partial thromboplastin time · Grade 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
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Coagulation
Partial thromboplastin time · Grade 3
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Coagulation
Prothrombin time INR · Grade 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
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Coagulation
Prothrombin time INR · Grade 3
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.Population: The safety analysis set included all enrolled participants who received at least one dose of study medication.
Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Following parameters were analyzed for laboratory examination: alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), total bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=15 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
n=10 Participants
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
n=12 Participants
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
ALT · Grade 0
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
10 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
ALT · Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
ALT · Grade 2
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Alkaline phosphatase · Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Alkaline phosphatase · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
AST · Grade 0
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
3 Participants
|
1 Participants
|
12 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Alkaline phosphatase · Grade 3
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
AST · Grade 1
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Alkaline phosphatase · Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
ALT · Grade 3
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
ALT · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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 Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Alkaline phosphatase · Grade 0
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
3 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
10 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
AST · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
AST · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
AST · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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 Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Bilirubin (total) · Grade 0
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
2 Participants
|
13 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Bilirubin (total) · Grade 1
|
1 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
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Bilirubin (total) · Grade 2
|
0 Participants
|
1 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
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Bilirubin (total) · Grade 3
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Bilirubin (total) · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Creatinine · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Creatinine · Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Creatinine · Grade 1
|
4 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
12 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Creatinine · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Creatinine · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypercalcemia · Grade 0
|
4 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
5 Participants
|
2 Participants
|
13 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypercalcemia · Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypercalcemia · Grade 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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypercalcemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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 Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypercalcemia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyperglycemia · Grade 0
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyperglycemia · Grade 1
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyperglycemia · Grade 2
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyperkalemia · Grade 2
|
0 Participants
|
0 Participants
|
1 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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyperglycemia · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyperglycemia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypernatremia · Grade 0
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyperkalemia · Grade 0
|
4 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
5 Participants
|
2 Participants
|
13 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
11 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyperkalemia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyperkalemia · Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 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
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyperkalemia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypermagnesemia · Grade 0
|
4 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
11 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypermagnesemia · Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 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
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypermagnesemia · Grade 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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypermagnesemia · Grade 3
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypermagnesemia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypernatremia · Grade 1
|
0 Participants
|
1 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
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypernatremia · Grade 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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypoalbuminemia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypernatremia · Grade 3
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypernatremia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypoalbuminemia · Grade 0
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
9 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
10 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypoalbuminemia · Grade 1
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypokalemia · Grade 0
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
11 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypoalbuminemia · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypoalbuminemia · Grade 3
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypocalcemia · Grade 0
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
1 Participants
|
10 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypocalcemia · Grade 4
|
1 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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypocalcemia · Grade 1
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypocalcemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypocalcemia · Grade 3
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypoglycemia · Grade 0
|
4 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
2 Participants
|
15 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypoglycemia · Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypoglycemia · Grade 2
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypoglycemia · Grade 3
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypoglycemia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypokalemia · Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypokalemia · Grade 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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypokalemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypokalemia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypomagnesemia · Grade 0
|
2 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypomagnesemia · Grade 1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypomagnesemia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypomagnesemia · Grade 3
|
0 Participants
|
0 Participants
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypomagnesemia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyponatremia · Grade 0
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyponatremia · Grade 1
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyponatremia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyponatremia · Grade 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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hyponatremia · Grade 3
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypophosphatemia · Grade 0
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
9 Participants
|
4 Participants
|
1 Participants
|
14 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypophosphatemia · Grade 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
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypophosphatemia · Grade 2
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypophosphatemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Chemistry
Hypophosphatemia · Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study drugs up to 28 days after the last dose of study drugs. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.Population: The safety analysis set included all enrolled participants who received at least one dose of study medication.
Laboratory abnormalities were graded per NCI CTCAE version 4.03 (Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) and those with at least 1 participant are presented here. Following parameter was analyzed for laboratory examination: urine protein.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=15 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=2 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
n=10 Participants
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
n=12 Participants
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Urinalysis
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Urinalysis
Grade 3
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Urinalysis
Grade 4
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Urinalysis
Grade 0
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
5 Participants
|
0 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities by Severity (All Cycles) - Urinalysis
Grade 1
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From baseline up to follow up (at least 28 days and no more than 35 days after discontinuation of treatment). Maximum duration between first and last dose: 842 days.Blood pressure (BP), including systolic BP (SBP) and diastolic BP (DBP), and pulse rate were recorded in sitting position.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=15 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
n=10 Participants
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
n=12 Participants
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Max increase from baseline in sitting DBP>=20 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Sitting SBP<=100 mmHg
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Sitting SBP>=160 mmHg
|
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
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Sitting DBP<=60 mmHg
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Sitting DBP>=100 mmHg
|
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
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Max increase from baseline in sitting DBP>=30 mmHg
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Sitting heart rate<50 bpm
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Sitting heart rate>120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Max increase from baseline in sitting SBP>=20 mmHg
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Max increase from baseline in sitting SBP>=40 mmHg
|
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
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Max increase from baseline in sitting SBP>=60 mmHg
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
Max increase from baseline in sitting DBP>=10 mmHg
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 7 days prior to Cycle 1 Day 1 for Arms A and B; pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 14 days prior to Cycle 1 Day 1 for Arm C.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=15 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Following Single IV Infusion Dose of PF-05212384 Alone - Plasma PF-05212384 (Arms A, B and C)
|
6455 ng/mL
Geometric Coefficient of Variation 30
|
9539 ng/mL
Geometric Coefficient of Variation 24
|
12090 ng/mL
Geometric Coefficient of Variation 21
|
7128 ng/mL
Geometric Coefficient of Variation 154
|
12420 ng/mL
Geometric Coefficient of Variation 27
|
4522 ng/mL
Geometric Coefficient of Variation 76
|
7297 ng/mL
Geometric Coefficient of Variation 6
|
7969 ng/mL
Geometric Coefficient of Variation 39
|
9548 ng/mL
Geometric Coefficient of Variation 20
|
13350 ng/mL
Geometric Coefficient of Variation 54
|
15170 ng/mL
Geometric Coefficient of Variation 63
|
11510 ng/mL
Geometric Coefficient of Variation 61
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
|
6703 ng/mL
Geometric Coefficient of Variation 57
|
8999 ng/mL
Geometric Coefficient of Variation 49
|
6783 ng/mL
Geometric Coefficient of Variation 24
|
4266 ng/mL
Geometric Coefficient of Variation 80
|
8261 ng/mL
Geometric Coefficient of Variation 12
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 1 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=10 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=12 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Maximum Observed Plasma Concentration (Cmax) Following Single IV Infusion Dose of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion)
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11340 ng/mL
Geometric Coefficient of Variation 60
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10690 ng/mL
Geometric Coefficient of Variation 44
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
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Maximum Observed Plasma Concentration (Cmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Docetaxel- Plasma PF-05212384 (Arm A)
|
8032 ng/mL
Geometric Coefficient of Variation 36
|
8095 ng/mL
Geometric Coefficient of Variation 33
|
10380 ng/mL
Geometric Coefficient of Variation 26
|
11110 ng/mL
Geometric Coefficient of Variation 53
|
10860 ng/mL
Geometric Coefficient of Variation 33
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
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Maximum Observed Plasma Concentration (Cmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B)
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10670 ng/mL
Geometric Coefficient of Variation 114
|
7830 ng/mL
Geometric Coefficient of Variation 104
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6273 ng/mL
Geometric Coefficient of Variation 102
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9619 ng/mL
Geometric Coefficient of Variation 57
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NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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18730 ng/mL
Geometric Coefficient of Variation 24
|
15000 ng/mL
Geometric Coefficient of Variation 19
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=13 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=1 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=6 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Maximum Observed Plasma Concentration (Cmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Dacomitinib - Plasma PF-05212384 (Arm C)
|
6739 ng/mL
Geometric Coefficient of Variation 50
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
|
6328 ng/mL
Geometric Coefficient of Variation 31
|
8547 ng/mL
Geometric Coefficient of Variation 48
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=10 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=11 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Maximum Observed Plasma Concentration (Cmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion)
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9027 ng/mL
Geometric Coefficient of Variation 52
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14670 ng/mL
Geometric Coefficient of Variation 32
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SECONDARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Maximum Observed Plasma Concentration (Cmax) Following Single IV Infusion Dose of Docetaxel Alone- Plasma Docetaxel (Arm A)
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946.7 ng/mL
Geometric Coefficient of Variation 116
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2451 ng/mL
Geometric Coefficient of Variation 23
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2528 ng/mL
Geometric Coefficient of Variation 19
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1529 ng/mL
Geometric Coefficient of Variation 93
|
1058 ng/mL
Geometric Coefficient of Variation 161
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SECONDARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Following Administration of Docetaxel IV Infusion in Combination With PF-05212384 - Plasma Docetaxel (Arm A)
|
1840 ng/mL
Geometric Coefficient of Variation 95
|
695.9 ng/mL
Geometric Coefficient of Variation 253
|
2457 ng/mL
Geometric Coefficient of Variation 18
|
1424 ng/mL
Geometric Coefficient of Variation 126
|
1300 ng/mL
Geometric Coefficient of Variation 238
|
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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: Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Following Single IV Infusion Dose of Cisplatin Alone - Plasma Platinum (Arm B)
|
3397 ng/mL
Geometric Coefficient of Variation 29
|
3950 ng/mL
Geometric Coefficient of Variation 1
|
3014 ng/mL
Geometric Coefficient of Variation 10
|
4041 ng/mL
Geometric Coefficient of Variation 14
|
3337 ng/mL
Geometric Coefficient of Variation 8
|
3474 ng/mL
Geometric Coefficient of Variation 31
|
3293 ng/mL
Geometric Coefficient of Variation 18
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had 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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SECONDARY outcome
Timeframe: Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Following Administration of Cisplatin IV Infusion in Combination With PF-05212384 - Plasma Platinum (Arm B)
|
3867 ng/mL
Geometric Coefficient of Variation 16
|
4201 ng/mL
Geometric Coefficient of Variation 7
|
3205 ng/mL
Geometric Coefficient of Variation 17
|
4086 ng/mL
Geometric Coefficient of Variation 10
|
3130 ng/mL
Geometric Coefficient of Variation 17
|
3665 ng/mL
Geometric Coefficient of Variation 23
|
3211 ng/mL
Geometric Coefficient of Variation 19
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had 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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SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=14 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
n=7 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Maximum Observed Plasma Concentration (Cmax) Following Multiple Oral Doses of Dacomitinib Alone - Plasma Dacomitinib (Arm C)
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41.04 ng/mL
Geometric Coefficient of Variation 33
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76.24 ng/mL
Geometric Coefficient of Variation 45
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34.17 ng/mL
Geometric Coefficient of Variation 61
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49.90 ng/mL
Geometric Coefficient of Variation 38
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SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is defined as maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=12 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
n=7 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Maximum Observed Plasma Concentration (Cmax) Following Multiple Oral Doses of Dacomitinib in Combination With PF-05212384 - Plasma Dacomitinib (Arm C)
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52.38 ng/mL
Geometric Coefficient of Variation 36
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NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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33.64 ng/mL
Geometric Coefficient of Variation 94
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48.10 ng/mL
Geometric Coefficient of Variation 72
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 7 days prior to Cycle 1 Day 1 for Arms A and B; pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 14 days prior to Cycle 1 Day 1 for Arm C.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
AUClast is defined as area under the curve from time zero to last quantifiable concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=1 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=8 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=14 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Single IV Infusion Dose of PF-05212384 Alone - Plasma PF-05212384 (Arms A, B and C)
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
|
12530 ng*hr/mL
Geometric Coefficient of Variation 26
|
15270 ng*hr/mL
Geometric Coefficient of Variation 21
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
|
18710 ng*hr/mL
Geometric Coefficient of Variation 28
|
6756 ng*hr/mL
Geometric Coefficient of Variation 65
|
8937 ng*hr/mL
Geometric Coefficient of Variation 21
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
|
14370 ng*hr/mL
Geometric Coefficient of Variation 16
|
17710 ng*hr/mL
Geometric Coefficient of Variation 14
|
24540 ng*hr/mL
Geometric Coefficient of Variation 35
|
24480 ng*hr/mL
Geometric Coefficient of Variation 30
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
|
9191 ng*hr/mL
Geometric Coefficient of Variation 32
|
13360 ng*hr/mL
Geometric Coefficient of Variation 35
|
10050 ng*hr/mL
Geometric Coefficient of Variation 26
|
9493 ng*hr/mL
Geometric Coefficient of Variation 32
|
10370 ng*hr/mL
Geometric Coefficient of Variation 23
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who have sufficient information to estimate at least 1 of the PK parameters of interest.
AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Docetaxel- Plasma PF-05212384 (Arm A)
|
10420 ng*hr/mL
Geometric Coefficient of Variation 44
|
15110 ng*hr/mL
Geometric Coefficient of Variation 22
|
15520 ng*hr/mL
Geometric Coefficient of Variation 26
|
14540 ng*hr/mL
Geometric Coefficient of Variation 56
|
15890 ng*hr/mL
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 7 days prior to Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=1 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=1 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B)
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14620 ng*hr/mL
Geometric Coefficient of Variation 75
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12690 ng*hr/mL
Geometric Coefficient of Variation 58
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NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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18920 ng*hr/mL
Geometric Coefficient of Variation 77
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NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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38850 ng*hr/mL
Geometric Coefficient of Variation 71
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27480 ng*hr/mL
Geometric Coefficient of Variation 46
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not calculated when fewer than 3 participants had reportable values. Individual values are 54700 and 69500 ng\*hr/mL, respectively.
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=13 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=1 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
n=6 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Dacomitinib - Plasma PF-05212384 (Arm C)
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10870 ng*hr/mL
Geometric Coefficient of Variation 36
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NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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9977 ng*hr/mL
Geometric Coefficient of Variation 22
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15910 ng*hr/mL
Geometric Coefficient of Variation 45
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 1 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=9 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=12 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Single IV Infusion Dose of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion)
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20180 ng*hr/mL
Geometric Coefficient of Variation 42
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24480 ng*hr/mL
Geometric Coefficient of Variation 22
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=7 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=9 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion)
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25250 ng*hr/mL
Geometric Coefficient of Variation 49
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31160 ng*hr/mL
Geometric Coefficient of Variation 27
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SECONDARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
AUClast is defined as area under the curve from time zero to last quantifiable concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Single IV Infusion Dose of Docetaxel Alone- Plasma Docetaxel (Arm A)
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1418 ng*hr/mL
Geometric Coefficient of Variation 88
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2748 ng*hr/mL
Geometric Coefficient of Variation 27
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2111 ng*hr/mL
Geometric Coefficient of Variation 11
|
1594 ng*hr/mL
Geometric Coefficient of Variation 64
|
1280 ng*hr/mL
Geometric Coefficient of Variation 63
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SECONDARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
AUClast is defined as area under the curve from time zero to last quantifiable concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Administration of Docetaxel in Combination With PF-05212384 - Plasma Docetaxel (Arm A)
|
2921 ng*hr/mL
Geometric Coefficient of Variation 60
|
2175 ng*hr/mL
Geometric Coefficient of Variation 26
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
|
1415 ng*hr/mL
Geometric Coefficient of Variation 115
|
1383 ng*hr/mL
Geometric Coefficient of Variation 136
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SECONDARY outcome
Timeframe: Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
AUClast is defined as area under the curve from time zero to last quantifiable concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Single IV Infusion Dose of Cisplatin Alone - Plasma Platinum (Arm B)
|
50210 ng*hr/mL
Geometric Coefficient of Variation 7
|
50860 ng*hr/mL
Geometric Coefficient of Variation 6
|
44240 ng*hr/mL
Geometric Coefficient of Variation 8
|
48870 ng*hr/mL
Geometric Coefficient of Variation 18
|
42910 ng*hr/mL
Geometric Coefficient of Variation 23
|
46560 ng*hr/mL
Geometric Coefficient of Variation 13
|
48350 ng*hr/mL
Geometric Coefficient of Variation 24
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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SECONDARY outcome
Timeframe: Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
AUClast is defined as area under the curve from time zero to last quantifiable concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=9 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Following Administration of Cisplatin IV Infusion in Combination With PF-05212384 - Plasma Platinum (Arm B)
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59390 ng*hr/mL
Geometric Coefficient of Variation 7
|
62990 ng*hr/mL
Geometric Coefficient of Variation 11
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
|
56170 ng*hr/mL
Geometric Coefficient of Variation 22
|
52940 ng*hr/mL
Geometric Coefficient of Variation 10
|
53470 ng*hr/mL
Geometric Coefficient of Variation 11
|
47500 ng*hr/mL
Geometric Coefficient of Variation 18
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=13 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
n=7 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple Oral Doses of Dacomitinib Alone - Plasma Dacomitinib (Arm C)
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818.8 ng*hr/mL
Geometric Coefficient of Variation 34
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1604 ng*hr/mL
Geometric Coefficient of Variation 36
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697.0 ng*hr/mL
Geometric Coefficient of Variation 62
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1040 ng*hr/mL
Geometric Coefficient of Variation 34
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SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
AUCtau is defined as area under the concentration-time profile from time 0 to time tau.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=12 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
n=7 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Area Under the Concentration-time Profile From Time 0 to Time Tau (AUCtau) Following Multiple Oral Doses of Dacomitinib in Combination With PF-05212384 - Plasma Dacomitinib (Arm C)
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1069 ng*hr/mL
Geometric Coefficient of Variation 38
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NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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703.8 ng*hr/mL
Geometric Coefficient of Variation 100
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NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 7 days prior to Cycle 1 Day 1 for Arms A and B; pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose 14 days prior to Cycle 1 Day 1 for Arm C.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=15 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Single IV Infusion Dose of PF-05212384 Alone - Plasma PF-05212384 (Arms A, B and C)
|
0.500 hr
Interval 0.5 to 0.567
|
0.500 hr
Interval 0.5 to 0.533
|
0.500 hr
Interval 0.5 to 0.5
|
0.550 hr
Interval 0.517 to 0.833
|
0.500 hr
Interval 0.5 to 0.533
|
0.584 hr
Interval 0.5 to 1.1
|
0.517 hr
Interval 0.5 to 0.533
|
0.500 hr
Interval 0.5 to 0.567
|
0.500 hr
Interval 0.5 to 0.517
|
0.533 hr
Interval 0.5 to 0.617
|
0.509 hr
Interval 0.5 to 1.32
|
0.500 hr
Interval 0.5 to 1.0
|
NA hr
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
|
0.500 hr
Interval 0.5 to 1.0
|
0.500 hr
Interval 0.5 to 0.567
|
0.533 hr
Interval 0.5 to 0.7
|
0.500 hr
Interval 0.5 to 0.983
|
0.533 hr
Interval 0.5 to 0.55
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Docetaxel- Plasma PF-05212384 (Arm A)
|
0.517 hr
Interval 0.467 to 0.55
|
0.500 hr
Interval 0.5 to 0.833
|
0.500 hr
Interval 0.5 to 0.533
|
0.517 hr
Interval 0.517 to 0.8
|
0.542 hr
Interval 0.5 to 0.583
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B)
|
0.500 hr
Interval 0.5 to 0.583
|
0.500 hr
Interval 0.5 to 0.533
|
0.550 hr
Interval 0.5 to 1.0
|
0.500 hr
Interval 0.5 to 0.517
|
0.675 hr
Interval 0.6 to 0.75
|
0.517 hr
Interval 0.5 to 2.0
|
0.517 hr
Interval 0.5 to 0.55
|
NA hr
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=13 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=1 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=6 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Dacomitinib - Plasma PF-05212384 (Arm C)
|
0.500 hr
Interval 0.5 to 0.9
|
NA hr
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
|
0.500 hr
Interval 0.5 to 0.6
|
0.500 hr
Interval 0.5 to 0.583
|
NA hr
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Single IV Infusion Dose of Docetaxel Alone- Plasma Docetaxel (Arm A)
|
1.12 hr
Interval 1.0 to 1.17
|
1.00 hr
Interval 1.0 to 1.5
|
1.00 hr
Interval 1.0 to 1.03
|
1.02 hr
Interval 1.0 to 1.17
|
1.05 hr
Interval 1.0 to 2.05
|
—
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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: Pre-dose, 1, 1.5, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Administration of Docetaxel IV Infusion in Combination With PF-05212384 - Plasma Docetaxel (Arm A)
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1.06 hr
Interval 1.0 to 1.13
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1.34 hr
Interval 1.0 to 2.17
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1.03 hr
Interval 1.0 to 1.07
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1.02 hr
Interval 1.02 to 1.02
|
1.13 hr
Interval 1.0 to 1.5
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SECONDARY outcome
Timeframe: Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Single IV Infusion Dose of Cisplatin Alone - Plasma Platinum (Arm B)
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2.08 hr
Interval 2.0 to 3.13
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2.12 hr
Interval 2.02 to 2.23
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2.10 hr
Interval 2.0 to 2.17
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2.00 hr
Interval 2.0 to 2.02
|
2.05 hr
Interval 2.0 to 2.08
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2.01 hr
Interval 1.98 to 2.28
|
2.00 hr
Interval 2.0 to 2.77
|
NA hr
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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SECONDARY outcome
Timeframe: Pre-dose, 2, 2.5, 3, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Administration of Cisplatin IV Infusion in Combination With PF-05212384 - Plasma Platinum (Arm B)
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2.05 hr
Interval 2.0 to 2.25
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2.00 hr
Interval 2.0 to 2.03
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2.00 hr
Interval 2.0 to 2.17
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2.00 hr
Interval 2.0 to 2.02
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2.00 hr
Interval 1.62 to 2.5
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2.02 hr
Interval 1.87 to 2.25
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2.01 hr
Interval 2.0 to 2.02
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NA hr
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 1 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=14 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
n=7 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple Oral Doses of Dacomitinib Alone - Plasma Dacomitinib (Arm C)
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4.08 hr
Interval 0.0 to 24.0
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6.00 hr
Interval 5.92 to 23.3
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6.00 hr
Interval 4.0 to 25.4
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5.97 hr
Interval 5.42 to 6.0
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SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=12 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
n=7 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple Oral Doses of Dacomitinib in Combination With PF-05212384 - Plasma Dacomitinib (Arm C)
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6.04 hr
Interval 4.0 to 25.1
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NA hr
Summary statistics are not presented if fewer than 3 participants had reportable parameter values.
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6.00 hr
Interval 5.63 to 24.2
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5.42 hr
Interval 4.0 to 5.5
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 1 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=10 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=12 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Single IV Infusion Dose of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion)
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0.517 hr
Interval 0.517 to 1.75
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0.600 hr
Interval 0.5 to 1.25
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SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 72, 96 and 168 (predose Day 8) hours post-dose on Cycle 2 Day 1.Population: All enrolled participants who started treatment and who had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is defined as time to reach maximum observed plasma concentration.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=10 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=11 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Multiple IV Infusion Doses of PF-05212384 in Combination With Cisplatin - Plasma PF-05212384 (Arm B Expansion)
|
0.517 hr
Interval 0.5 to 1.5
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0.500 hr
Interval 0.467 to 1.0
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SECONDARY outcome
Timeframe: BaselinePopulation: The serum pharmacodynamic analysis set was defined as all enrolled participants who started treatment and had a baseline and at least one post baseline measurement.
A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This study employed metabolic biomarkers such as glucose as pharmacodynamics markers for dual PI3K/mTOR inhibition.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=19 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=32 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=31 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Mean Serum Biomarkers for Glucose - Baseline
In population of BC
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106.80 mg/dL
Standard Deviation 18.820
|
—
|
95.07 mg/dL
Standard Deviation 12.019
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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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—
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—
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—
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Mean Serum Biomarkers for Glucose - Baseline
In population of NSCLC
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99.56 mg/dL
Standard Deviation 15.316
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100.97 mg/dL
Standard Deviation 9.154
|
97.00 mg/dL
Standard Deviation 10.10
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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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Mean Serum Biomarkers for Glucose - Baseline
In population of prostate cancer
|
124.51 mg/dL
Standard Deviation 20.624
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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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—
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—
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Mean Serum Biomarkers for Glucose - Baseline
In population of OC
|
—
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102.71 mg/dL
Standard Deviation 15.29
|
—
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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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—
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—
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—
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—
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—
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Mean Serum Biomarkers for Glucose - Baseline
In population of TCC
|
—
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109.70 mg/dL
Standard Deviation 18.335
|
—
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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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—
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—
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—
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—
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—
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Mean Serum Biomarkers for Glucose - Baseline
In population of TNBC
|
—
|
95.66 mg/dL
Standard Deviation 10.659
|
—
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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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—
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—
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—
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—
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—
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—
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Mean Serum Biomarkers for Glucose - Baseline
In population of head and neck cancer
|
—
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—
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90.68 mg/dL
Standard Deviation 14.422
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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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—
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—
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—
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—
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—
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—
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Mean Serum Biomarkers for Glucose - Baseline
In population of oesophageal carcinoma
|
—
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—
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103.54 mg/dL
Standard Deviation 14.970
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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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—
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—
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—
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—
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SECONDARY outcome
Timeframe: End of treatment. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.Population: The serum pharmacodynamic analysis set was defined as all enrolled participants who started treatment and had a baseline and at least one post baseline measurement.
A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as glucose as pharmacodynamics markers for dual PI3K/mTOR inhibition.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=15 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=29 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=29 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Serum Biomarkers for Glucose - End of Treatment
In population of BC
|
120.00 mg/dL
Standard Deviation 37.242
|
—
|
99.84 mg/dL
Standard Deviation 12.820
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Glucose - End of Treatment
In population of NSCLC
|
96.13 mg/dL
Standard Deviation 10.500
|
108.11 mg/dL
Standard Deviation 10.698
|
97.50 mg/dL
Standard Deviation 17.046
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Glucose - End of Treatment
In population of prostate cancer
|
136.91 mg/dL
Standard Deviation 59.555
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
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—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Glucose - End of Treatment
In population of OC
|
—
|
143.26 mg/dL
Standard Deviation 34.404
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Glucose - End of Treatment
In population of TCC
|
—
|
100.71 mg/dL
Standard Deviation 24.112
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Glucose - End of Treatment
In population of TNBC
|
—
|
108.29 mg/dL
Standard Deviation 36.210
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Glucose - End of Treatment
In population of head and neck cancer
|
—
|
—
|
90.19 mg/dL
Standard Deviation 15.367
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Glucose - End of Treatment
In population of oesophageal carcinoma
|
—
|
—
|
1.14 mg/dL
Standard Deviation 0.210
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: The serum pharmacodynamic analysis set was defined as all enrolled participants who started treatment and had a baseline and at least one post baseline measurement.
A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as insulin as pharmacodynamics markers for dual PI3K/mTOR inhibition.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=15 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=27 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=23 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Serum Biomarkers for Insulin - Baseline
In population of oesophageal carcinoma
|
—
|
—
|
338.98 microunits/mL
Standard Deviation 441.323
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Insulin - Baseline
In population of BC
|
10.93 microunits/mL
Standard Deviation 3.942
|
—
|
155.14 microunits/mL
Standard Deviation 212.916
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Insulin - Baseline
In population of NSCLC
|
28.61 microunits/mL
Standard Deviation 56.678
|
710.50 microunits/mL
Standard Deviation 1346.142
|
11.53 microunits/mL
Standard Deviation 4.279
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Insulin - Baseline
In population of prostate cancer
|
12.65 microunits/mL
Standard Deviation 13.268
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Insulin - Baseline
In population of OC
|
—
|
12.50 microunits/mL
Standard Deviation 1.980
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Insulin - Baseline
In population of TCC
|
—
|
20.68 microunits/mL
Standard Deviation 3.446
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Insulin - Baseline
In population of TNBC
|
—
|
81.16 microunits/mL
Standard Deviation 204.586
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Serum Biomarkers for Insulin - Baseline
In population of head and neck cancer
|
—
|
—
|
101.31 microunits/mL
Standard Deviation 187.285
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End of treatment. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.Population: The serum pharmacodynamic analysis set was defined as all enrolled participants who started treatment and had a baseline and at least one post baseline measurement.
A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as insulin as pharmacodynamics markers for dual PI3K/mTOR inhibition.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=15 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=27 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=23 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Mean Serum Biomarkers for Insulin - End of Treatment
In population of BC
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19.17 microunits/mL
Standard Deviation 8.578
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—
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318.62 microunits/mL
Standard Deviation 365.374
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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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—
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—
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—
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—
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—
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—
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Mean Serum Biomarkers for Insulin - End of Treatment
In population of NSCLC
|
22.34 microunits/mL
Standard Deviation 20.913
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832.87 microunits/mL
Standard Deviation 806.616
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18.26 microunits/mL
Standard Deviation 10.559
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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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—
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—
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—
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—
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—
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—
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Mean Serum Biomarkers for Insulin - End of Treatment
In population of prostate cancer
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13.73 microunits/mL
Standard Deviation 17.017
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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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—
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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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Mean Serum Biomarkers for Insulin - End of Treatment
In population of OC
|
—
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80.30 microunits/mL
Standard Deviation 81.459
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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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—
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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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Mean Serum Biomarkers for Insulin - End of Treatment
In population of TCC
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—
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41.65 microunits/mL
Standard Deviation 8.505
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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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—
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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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Mean Serum Biomarkers for Insulin - End of Treatment
In population of TNBC
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—
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56.69 microunits/mL
Standard Deviation 120.565
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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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—
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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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Mean Serum Biomarkers for Insulin - End of Treatment
In population of head and neck cancer
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—
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—
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289.32 microunits/mL
Standard Deviation 606.589
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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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—
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—
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—
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—
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—
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—
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Mean Serum Biomarkers for Insulin - End of Treatment
In population of oesophageal carcinoma
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—
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—
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436.94 microunits/mL
Standard Deviation 612.108
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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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—
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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: BaselinePopulation: The serum pharmacodynamic analysis set was defined as all enrolled participants who started treatment and had a baseline and at least one post baseline measurement.
A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as hemoglobin A1c (HbA1c) as pharmacodynamics markers for dual PI3K/mTOR inhibition.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=13 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=26 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=18 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - Baseline
In population of BC
|
7.92 Percentage of HbA1c
Standard Deviation 0.115
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—
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7.00 Percentage of HbA1c
Standard Deviation 1.742
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - Baseline
In population of NSCLC
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7.27 Percentage of HbA1c
Standard Deviation 1.074
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6.65 Percentage of HbA1c
Standard Deviation 0.931
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5.13 Percentage of HbA1c
Standard Deviation 0.065
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - Baseline
In population of prostate cancer
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8.03 Percentage of HbA1c
Standard Deviation 0.465
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - Baseline
In population of OC
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—
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7.70 Percentage of HbA1c
Standard Deviation 0.354
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - Baseline
In population of TCC
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—
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7.65 Percentage of HbA1c
Standard Deviation 0.696
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - Baseline
In population of TNBC
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—
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7.18 Percentage of HbA1c
Standard Deviation 1.195
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - Baseline
In population of head and neck cancer
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—
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—
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7.50 Percentage of HbA1c
Standard Deviation 1.107
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - Baseline
In population of oesophageal carcinoma
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—
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—
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7.00 Percentage of HbA1c
Standard Deviation 1.065
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SECONDARY outcome
Timeframe: End of treatment. Maximum duration between first and last dose: 505 days for Arm A, 414 days for Arm B, 842 days for Arm C, 728 days for Arm B Expansion.Population: The serum pharmacodynamics analysis set was defined as all enrolled participants who started treatment and had a baseline and at least one post baseline measurement.
A phosphatidylinositol 3 kinase/mammalian target of rapamycin (PI3K/mTOR) inhibitor should disrupt the cellular uptake and metabolism of glucose. This studies employed metabolic biomarkers such as hemoglobin A1c (HbA1c) as pharmacodynamics markers for dual PI3K/mTOR inhibition.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=13 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=26 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=18 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - End of Treatment
In population of BC
|
NA Percentage of HbA1c
Standard Deviation NA
Summary statistics are not presented if fewer than 2 participants had reportable parameter values.
|
—
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8.39 Percentage of HbA1c
Standard Deviation 1.050
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - End of Treatment
In population of NSCLC
|
7.70 Percentage of HbA1c
Standard Deviation 1.087
|
6.74 Percentage of HbA1c
Standard Deviation 1.572
|
NA Percentage of HbA1c
Standard Deviation NA
Summary statistics are not presented if fewer than 2 participants had reportable parameter values.
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - End of Treatment
In population of prostate cancer
|
8.42 Percentage of HbA1c
Standard Deviation 1.332
|
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - End of Treatment
In population of OC
|
—
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25.10 Percentage of HbA1c
Standard Deviation 22.698
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - End of Treatment
In population of TCC
|
—
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7.72 Percentage of HbA1c
Standard Deviation 0.551
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - End of Treatment
In population of TNBC
|
—
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7.72 Percentage of HbA1c
Standard Deviation 1.408
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - End of Treatment
In population of head and neck cancer
|
—
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—
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7.72 Percentage of HbA1c
Standard Deviation 1.012
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Mean Serum Biomarkers for Hemoglobin A1c (HbA1c) - End of Treatment
In population of oesophageal carcinoma
|
—
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—
|
7.61 Percentage of HbA1c
Standard Deviation 1.404
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SECONDARY outcome
Timeframe: BaselinePopulation: The molecular profiling tumor analysis set was defined as all enrolled participants who start treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.
Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
BRAF - BRAF mutaion status (mutation detected)
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0 Percentage of Participants
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0 Percentage of Participants
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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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—
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
BRAF - BRAF mutaion status (mutation not detected)
|
33.3 Percentage of Participants
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40.0 Percentage of Participants
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
BRAF - V600E (mutation detected)
|
0 Percentage of Participants
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0 Percentage of Participants
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
BRAF - V600E (mutation not detected)
|
66.7 Percentage of Participants
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40.0 Percentage of Participants
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY12ALA (mutation detected)
|
0 Percentage of Participants
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0 Percentage of Participants
|
—
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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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|
Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY12ALA (mutation not detected)
|
100.0 Percentage of Participants
|
80.0 Percentage of Participants
|
—
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY12ARG (mutation detected)
|
0 Percentage of Participants
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0 Percentage of Participants
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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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|
Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY12ARG (mutation not detected)
|
100.0 Percentage of Participants
|
80.0 Percentage of Participants
|
—
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—
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—
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—
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—
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—
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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY12ASP (mutation detected)
|
0 Percentage of Participants
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0 Percentage of Participants
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY12ASP (mutation not detected)
|
100.0 Percentage of Participants
|
80.0 Percentage of Participants
|
—
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—
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—
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—
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—
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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY12CYS (mutation detected)
|
0 Percentage of Participants
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0 Percentage of Participants
|
—
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—
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—
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—
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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY12CYS (mutation not detected)
|
100.0 Percentage of Participants
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80.0 Percentage of Participants
|
—
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—
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—
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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY12SER (mutation detected)
|
0 Percentage of Participants
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0 Percentage of Participants
|
—
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY12SER (mutation not detected)
|
100.0 Percentage of Participants
|
80.0 Percentage of Participants
|
—
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—
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—
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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY12VAL (mutation detected)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
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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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|
Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY12VAL (mutation not detected)
|
100.0 Percentage of Participants
|
80.0 Percentage of Participants
|
—
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY13ASP (mutation detected)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Breast Cancer - Arms A and C
KRAS - GLY13ASP (mutation not detected)
|
100.0 Percentage of Participants
|
80.0 Percentage of Participants
|
—
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—
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SECONDARY outcome
Timeframe: BaselinePopulation: The molecular profiling tumor analysis set was defined as all enrolled participants who start treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.
Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=7 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
BRAF - BRAF mutaion status (mutation detected)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
BRAF - BRAF mutaion status (mutation not detected)
|
14.3 Percentage of Participants
|
80.0 Percentage of Participants
|
25.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
BRAF - V600E (mutation detected)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
BRAF - V600E (mutation not detected)
|
85.7 Percentage of Participants
|
20.0 Percentage of Participants
|
75.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY12ALA (mutation detected)
|
0 Percentage of Participants
|
5 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY12ALA (mutation not detected)
|
85.7 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY12ARG (mutation detected)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY12ARG (mutation not detected)
|
85.7 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY12ASP (mutation detected)
|
14.3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY12ASP (mutation not detected)
|
71.4 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY12CYS (mutation detected)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY12CYS (mutation not detected)
|
85.7 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY12SER (mutation detected)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY12SER (mutation not detected)
|
85.7 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY12VAL (mutation detected)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY12VAL (mutation not detected)
|
85.7 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY13ASP (mutation detected)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Non-Small Cell Lung Cancer - Arms A, B and C
KRAS - GLY13ASP (mutation not detected)
|
85.7 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
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—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: The molecular profiling tumor analysis set was defined as all enrolled participants who start treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.
Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
BRAF - BRAF mutaion status (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY12ARG (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY12ARG (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
BRAF - BRAF mutaion status (mutation not detected)
|
66.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
BRAF - V600E (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY13ASP (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
BRAF - V600E (mutation not detected)
|
33.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY12ALA (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY12ALA (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY12ASP (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY12ASP (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY12CYS (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY12CYS (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY12SER (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY12SER (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY12VAL (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY12VAL (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Prostate Cancer - Arm A
KRAS - GLY13ASP (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: The molecular profiling tumor analysis set was defined as all enrolled participants who start treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.
Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation category was BRAF mutation status. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=2 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY12ASP (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
BRAF - BRAF mutaion status (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
BRAF - BRAF mutaion status (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY12ALA (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY12ALA (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY12ARG (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY12ARG (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY12ASP (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY12CYS (mutation detected)
|
50.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY12CYS (mutation not detected)
|
50.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY12SER (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY12SER (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY12VAL (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY12VAL (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
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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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—
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—
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—
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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY13ASP (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Ovarian Cancer - Arm B
KRAS - GLY13ASP (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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: BaselinePopulation: The molecular profiling tumor analysis set was defined as all enrolled participants who start treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.
Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=7 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
BRAF - V600E (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
BRAF - V600E (mutation not detected)
|
71.4 Percentage of Participants
|
—
|
—
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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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—
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—
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—
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—
|
—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY12ALA (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
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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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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY12ALA (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
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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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—
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—
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—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY12ARG (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY12ARG (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
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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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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
BRAF - BRAF mutaion status (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
BRAF - BRAF mutaion status (mutation not detected)
|
28.6 Percentage of Participants
|
—
|
—
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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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—
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—
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—
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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY12ASP (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY12ASP (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
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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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—
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—
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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY12CYS (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
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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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—
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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY12CYS (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
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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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—
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—
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—
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—
|
—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY12SER (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
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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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—
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—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY12SER (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY12VAL (mutation detected)
|
14.3 Percentage of Participants
|
—
|
—
|
—
|
—
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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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—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY12VAL (mutation not detected)
|
85.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY13ASP (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Transitional Cell Carcinoma - Arm B
KRAS - GLY13ASP (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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: BaselinePopulation: The molecular profiling tumor analysis set was defined as all enrolled participants who started treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.
Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=13 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY12SER (mutation detected)
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0 Percentage of Participants
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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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—
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY12SER (mutation not detected)
|
100.0 Percentage of Participants
|
—
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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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—
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY12VAL (mutation detected)
|
0 Percentage of Participants
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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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—
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY12VAL (mutation not detected)
|
100.0 Percentage of Participants
|
—
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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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—
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—
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—
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—
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—
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—
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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY13ASP (mutation detected)
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0 Percentage of Participants
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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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—
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—
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—
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—
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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY13ASP (mutation not detected)
|
100.0 Percentage of Participants
|
—
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
BRAF - BRAF mutaion status (mutation detected)
|
0 Percentage of Participants
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
BRAF - BRAF mutaion status (mutation not detected)
|
38.5 Percentage of Participants
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
BRAF - V600E (mutation detected)
|
0 Percentage of Participants
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
BRAF - V600E (mutation not detected)
|
38.5 Percentage of Participants
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—
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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY12ALA (mutation detected)
|
0 Percentage of Participants
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—
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—
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—
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—
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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY12ALA (mutation not detected)
|
100.0 Percentage of Participants
|
—
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—
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—
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—
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—
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—
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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY12ARG (mutation detected)
|
0 Percentage of Participants
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—
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—
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—
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—
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—
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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY12ARG (mutation not detected)
|
100.0 Percentage of Participants
|
—
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—
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—
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—
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—
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—
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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY12ASP (mutation detected)
|
0 Percentage of Participants
|
—
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY12ASP (mutation not detected)
|
100.0 Percentage of Participants
|
—
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY12CYS (mutation detected)
|
0 Percentage of Participants
|
—
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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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Percentage of Participants With BRAF and KRAS Mutations in Population of Triple Negative Breast Cancer - Arm B
KRAS - GLY12CYS (mutation not detected)
|
100.0 Percentage of Participants
|
—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: BaselinePopulation: The molecular profiling tumor analysis set was defined as all enrolled participants who started treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.
Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=10 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY12ALA (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
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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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—
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—
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—
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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY12ARG (mutation detected)
|
0 Percentage of Participants
|
—
|
—
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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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—
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—
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—
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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY12ARG (mutation not detected)
|
100.0 Percentage of Participants
|
—
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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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—
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—
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—
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—
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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
BRAF - BRAF mutaion status (mutation detected)
|
0 Percentage of Participants
|
—
|
—
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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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—
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—
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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
BRAF - BRAF mutaion status (mutation not detected)
|
10.0 Percentage of Participants
|
—
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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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—
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—
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—
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—
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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
BRAF - V600E (mutation detected)
|
0 Percentage of Participants
|
—
|
—
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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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—
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—
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—
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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
BRAF - V600E (mutation not detected)
|
90.0 Percentage of Participants
|
—
|
—
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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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—
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—
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—
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—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY12ALA (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY12ASP (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
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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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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY12ASP (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
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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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—
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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY12CYS (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
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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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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY12CYS (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
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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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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY12SER (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY12SER (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
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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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—
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—
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—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY12VAL (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY12VAL (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY13ASP (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Head and Neck Cancer - Arm C
KRAS - GLY13ASP (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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: BaselinePopulation: The molecular profiling tumor analysis set was defined as all enrolled participants who started treatment and had baseline archived tumor biopsy formalin fixed paraffin embedded (FFPE) sample (or fresh FFPE if archived was not available) successfully analyzed for at least one of the selected biomarkers.
Biopsies were obtained at screening and after drug administration. These samples were analyzed predominantly for phosphoprotein biomarkers indicative of pathway modulation, or for genetic markers correlated to drug sensitivity (eg, emerging KRAS mutation and BRAF mutation). BRAF mutation categories included BRAF mutation status and V600E. KRAS mutation categories included GLY12ALA, GLY12ARG, GLY12ASP, GLY12CYS, GLY12SER, GLY12VAL and GLY13ASP.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=7 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
BRAF - BRAF mutaion status (mutation not detected)
|
42.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
BRAF - V600E (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
BRAF - V600E (mutation not detected)
|
42.9 Percentage of Participants
|
—
|
—
|
—
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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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—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY12ALA (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY12ALA (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY12ARG (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY12ARG (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY12ASP (mutation detected)
|
14.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY12ASP (mutation not detected)
|
85.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY12CYS (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY12CYS (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY12SER (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY12SER (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY12VAL (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY12VAL (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY13ASP (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
KRAS - GLY13ASP (mutation not detected)
|
100.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With BRAF and KRAS Mutations in Population of Oesophageal Carcinoma - Arm C
BRAF - BRAF mutaion status (mutation detected)
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 1 (for Arm B Expansion), Cycle 1 Day 2 (for Arms A, B and C), Cycle 2 Day 1 (for Arms A, B and C), Day 1 for each cycle (Cycles 3-36, for Arms B Expansion and C) and end of treatment (up to 2 years, for Arms B Expansion and C).Population: The QTc analysis set was defined as all enrolled participants who had at least one ECG assessment after receiving study drug or study drugs.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of 30 to less than (\<) 60 msec(borderline) and greater than or equal to (\>=) 60 msec (prolonged) were summarized.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=1 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=1 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=1 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=11 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=2 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=2 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
n=10 Participants
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
n=12 Participants
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Increase From Baseline in Corrected QT (QTc) Interval
Maximum QTcB interval (Bazett's correction) increase from baseline (msec) · Change > 60
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Maximum Increase From Baseline in Corrected QT (QTc) Interval
Maximum QTcB interval (Bazett's correction) increase from baseline (msec) · 30 < Change <= 60
|
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
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Maximum Increase From Baseline in Corrected QT (QTc) Interval
Maximum QTcF interval (Fridericia's correction) increase from baseline (msec) · Change <= 30
|
4 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
3 Participants
|
1 Participants
|
11 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants With Maximum Increase From Baseline in Corrected QT (QTc) Interval
Maximum QTcF interval (Fridericia's correction) increase from baseline (msec) · 30 < Change <= 60
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Maximum Increase From Baseline in Corrected QT (QTc) Interval
Maximum QTcF interval (Fridericia's correction) increase from baseline (msec) · Change > 60
|
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
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Increase From Baseline in Corrected QT (QTc) Interval
Maximum QTcB interval (Bazett's correction) increase from baseline (msec) · Change <= 30
|
4 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
3 Participants
|
1 Participants
|
10 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 1 (for Arm B Expansion), Cycle 1 Day 2 (for Arms A, B and C), Cycle 2 Day 1 (for Arms A, B and C), Day 1 for each cycle (Cycles 3-36, for Arms B Expansion and C) and end of treatment (up to 2 years, for Arms B Expansion and C).Population: The QTc analysis set was defined as all enrolled participants who had at least one ECG assessment after receiving study drug or study drugs.
QT interval corrected using Fridericia's formula (QTcF) and Bazette's formula (QTcB): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (\<) 450 milliseconds (msec), 450 msec to 480 msec, 480 msec to 500 msec, and more than (\>) 500 msec.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
n=14 Participants
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=2 Participants
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
n=10 Participants
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
n=12 Participants
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Corrected QT (QTc) Interval Meeting Pre-defined Criteria
Maximum QTcB interval (Bazett's correction) (msec) · < 450
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
11 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Maximum Corrected QT (QTc) Interval Meeting Pre-defined Criteria
Maximum QTcB interval (Bazett's correction) (msec) · 450 <= Value <= 480
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Maximum Corrected QT (QTc) Interval Meeting Pre-defined Criteria
Maximum QTcB interval (Bazett's correction) (msec) · 480 < Value <=500
|
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
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Maximum Corrected QT (QTc) Interval Meeting Pre-defined Criteria
Maximum QTcB interval (Bazett's correction) (msec) · > 500
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Maximum Corrected QT (QTc) Interval Meeting Pre-defined Criteria
Maximum QTcF interval (Fridericia's correction) (msec) · < 450
|
4 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
10 Participants
|
4 Participants
|
2 Participants
|
14 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Maximum Corrected QT (QTc) Interval Meeting Pre-defined Criteria
Maximum QTcF interval (Fridericia's correction) (msec) · 450 <= Value <= 480
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 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
|
5 Participants
|
|
Number of Participants With Maximum Corrected QT (QTc) Interval Meeting Pre-defined Criteria
Maximum QTcF interval (Fridericia's correction) (msec) · 480 < Value <=500
|
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
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Maximum Corrected QT (QTc) Interval Meeting Pre-defined Criteria
Maximum QTcF interval (Fridericia's correction) (msec) · > 500
|
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
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 18 months.Population: The response analysis set included all participants who received at least one dose of study medication, had the disease under study, and who had an adequate baseline tumor assessment.
Percentage of participants with objective response based on the assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm) and no new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response - Arm A
|
0 Percentage of Participants
Interval 0.0 to 60.2
|
40 Percentage of Participants
Interval 5.3 to 85.3
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
20 Percentage of Participants
Interval 0.5 to 71.6
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
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—
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—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 18 months.Population: The response analysis set included all participants who received at least one dose of study medication, had the disease under study, and who had an adequate baseline tumor assessment.
Percentage of participants with objective response based on the assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm) and no new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=10 Participants
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=5 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=2 Participants
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response - Arm B
|
0.0 Percentage of Participants
Interval 0.0 to 60.2
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
20.0 Percentage of Participants
Interval 2.5 to 55.6
|
20.0 Percentage of Participants
Interval 0.5 to 71.6
|
50.0 Percentage of Participants
Interval 1.3 to 98.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 18 months.Population: The response analysis set included all participants who received at least one dose of study medication, had the disease under study, and who had an adequate baseline tumor assessment.
Percentage of participants with objective response based on the assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm) and no new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=15 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=7 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=3 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response - Arm C
|
20.0 Percentage of Participants
Interval 4.3 to 48.1
|
25.0 Percentage of Participants
Interval 0.6 to 80.6
|
14.3 Percentage of Participants
Interval 0.4 to 57.9
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
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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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—
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—
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SECONDARY outcome
Timeframe: Baseline up to 18 months.Population: The response analysis set included all participants who received at least one dose of study medication, had the disease under study, and who had an adequate baseline tumor assessment.
Percent of participants with confirmed complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST). Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm) and no new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions. SD was defined as not qualifying for CR, PR, Progressive Disease (PD).
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=10 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=12 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Clinical Benefit Response Rate - Arm B Expansion
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60.0 Percentage of participants
Interval 26.2 to 87.8
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50.0 Percentage of participants
Interval 21.1 to 78.9
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SECONDARY outcome
Timeframe: Baseline up to 18 months.Population: The response analysis set included all participants who received at least one dose of study medication, had the disease under study, had an adequate baseline tumor assessment, and who with objective response.
Duration of response was calculated from first date of partial response (PR) or complete response (CR) to the date of progression or death due to any cause. In the event of no progression or death, the last tumor assessment date without progression was used in this calculation.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=4 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Duration of Response - Arm B Expansion
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6.9 month
Interval 2.6 to 9.9
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NA month
Interval 7.4 to
The value marked "NA" was not estimable due to insufficient number of participants with events.
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SECONDARY outcome
Timeframe: Baseline up to 18 months.Population: The response analysis set included all participants who received at least one dose of study medication, had the disease under study, and who had an adequate baseline tumor assessment.
Progression free survival (PFS) defined as the time from first dose of study treatment to date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as first event date minus the date of first dose of study medication plus 1 . Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=10 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=12 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Progression Free Survival - Arm B Expansion
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4.8 month
Interval 0.8 to 7.0
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8.5 month
Interval 1.2 to
The value marked "NA" was not estimable due to insufficient number of participants with events.
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SECONDARY outcome
Timeframe: Baseline, Day 1 and Day 8 of Cycles 1 and 2, Day 1 of Cycles 3 to 16.Population: All enrolled participants who started treatment on study drug and who completed a baseline assessment and at least one post baseline assessment.
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=8 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=11 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Baseline
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64.58 Score on a scale
Standard Deviation 18.232
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58.33 Score on a scale
Standard Deviation 19.003
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 1 Day 8
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50.00 Score on a scale
Standard Deviation 23.570
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50.00 Score on a scale
Standard Deviation 26.058
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 2 Day 1
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53.12 Score on a scale
Standard Deviation 28.499
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56.82 Score on a scale
Standard Deviation 17.802
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 2 Day 8
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50.00 Score on a scale
Standard Deviation 25.911
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52.38 Score on a scale
Standard Deviation 12.468
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 3 Day 1
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56.25 Score on a scale
Standard Deviation 38.112
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57.41 Score on a scale
Standard Deviation 16.896
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 4 Day 1
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45.84 Score on a scale
Standard Deviation 31.551
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48.15 Score on a scale
Standard Deviation 19.886
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 5 Day 1
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45.00 Score on a scale
Standard Deviation 32.059
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51.04 Score on a scale
Standard Deviation 23.753
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 6 Day 1
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55.00 Score on a scale
Standard Deviation 33.125
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51.39 Score on a scale
Standard Deviation 15.293
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 7 Day 1
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46.67 Score on a scale
Standard Deviation 26.745
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52.78 Score on a scale
Standard Deviation 20.185
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 8 Day 1
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51.67 Score on a scale
Standard Deviation 25.274
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44.44 Score on a scale
Standard Deviation 20.860
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 9 Day 1
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56.25 Score on a scale
Standard Deviation 20.835
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56.25 Score on a scale
Standard Deviation 24.883
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 10 Day 1
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66.67 Score on a scale
Standard Deviation 16.665
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56.25 Score on a scale
Standard Deviation 15.778
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 11 Day 1
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54.17 Score on a scale
Standard Deviation 17.678
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54.17 Score on a scale
Standard Deviation 20.971
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 12 Day 1
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62.50 Score on a scale
Standard Deviation 29.458
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52.08 Score on a scale
Standard Deviation 23.936
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 13 Day 1
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NA Score on a scale
Standard Deviation NA
Summary statistics are not presented if fewer than 2 participants had reportable parameter values.
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63.89 Score on a scale
Standard Deviation 17.346
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 14 Day 1
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NA Score on a scale
Standard Deviation NA
Summary statistics are not presented if fewer than 2 participants had reportable parameter values.
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58.33 Score on a scale
Standard Deviation 25.000
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 15 Day 1
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NA Score on a scale
Standard Deviation NA
Summary statistics are not presented if fewer than 2 participants had reportable parameter values.
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61.11 Score on a scale
Standard Deviation 19.243
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Mean Observed Score Values for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 16 Day 1
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NA Score on a scale
Standard Deviation NA
Summary statistics are not presented if fewer than 2 participants had reportable parameter values.
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55.56 Score on a scale
Standard Deviation 9.624
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SECONDARY outcome
Timeframe: Baseline, Day 1 and Day 8 of Cycles 1 and 2, Day 1 of Cycles 3 to 16.Population: All enrolled participants who started treatment on study drug and who completed a baseline assessment and at least one post baseline assessment.
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
Outcome measures
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=8 Participants
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A2: 110 mg PF-05212384 + Docetaxel
n=11 Participants
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A3: 130 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A4: 150 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm A5: 180 mg PF-05212384 + Docetaxel
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
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Arm B1: 90 mg PF-05212384 + Cisplatin
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B2: 110 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B3: 130 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B4: 150 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B5: 180 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B6: 215 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B7: 260 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm B8: 310 mg PF-05212384 + Cisplatin
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
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Arm C1: 90 mg PF-05212384 + 30 mg Dacomitinib
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
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Arm 1: 1L Metastasic
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Arm 2: 2L/3L Metastatic
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 1 Day 8
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-16.67 Score on a scale
Standard Deviation 23.570
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-9.17 Score on a scale
Standard Deviation 16.411
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 2 Day 1
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-11.46 Score on a scale
Standard Deviation 24.372
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-1.52 Score on a scale
Standard Deviation 9.734
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 2 Day 8
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-14.28 Score on a scale
Standard Deviation 26.665
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-7.14 Score on a scale
Standard Deviation 25.200
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 3 Day 1
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-10.42 Score on a scale
Standard Deviation 33.591
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1.85 Score on a scale
Standard Deviation 18.054
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 4 Day 1
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-14.58 Score on a scale
Standard Deviation 29.165
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-7.41 Score on a scale
Standard Deviation 20.601
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 5 Day 1
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-21.67 Score on a scale
Standard Deviation 34.660
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-5.21 Score on a scale
Standard Deviation 30.839
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 6 Day 1
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-11.67 Score on a scale
Standard Deviation 24.719
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-8.33 Score on a scale
Standard Deviation 22.361
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 7 Day 1
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-20.00 Score on a scale
Standard Deviation 26.743
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0.00 Score on a scale
Standard Deviation 10.545
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 8 Day 1
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-15.00 Score on a scale
Standard Deviation 18.063
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-8.33 Score on a scale
Standard Deviation 31.178
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 9 Day 1
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-4.16 Score on a scale
Standard Deviation 20.971
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-4.16 Score on a scale
Standard Deviation 22.047
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 10 Day 1
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5.55 Score on a scale
Standard Deviation 25.458
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-4.16 Score on a scale
Standard Deviation 30.808
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 11 Day 1
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0.01 Score on a scale
Standard Deviation 23.568
|
-6.25 Score on a scale
Standard Deviation 24.883
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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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—
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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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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 12 Day 1
|
8.34 Score on a scale
Standard Deviation 35.348
|
-8.34 Score on a scale
Standard Deviation 32.631
|
—
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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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—
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—
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—
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—
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—
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—
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 13 Day 1
|
NA Score on a scale
Standard Deviation NA
Summary statistics are not presented if fewer than 2 participants had reportable parameter values.
|
0.00 Score on a scale
Standard Deviation 30.044
|
—
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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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—
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—
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—
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—
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—
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—
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 14 Day 1
|
NA Score on a scale
Standard Deviation NA
Summary statistics are not presented if fewer than 2 participants had reportable parameter values.
|
-5.56 Score on a scale
Standard Deviation 39.381
|
—
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—
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—
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 15 Day 1
|
NA Score on a scale
Standard Deviation NA
Summary statistics are not presented if fewer than 2 participants had reportable parameter values.
|
-2.78 Score on a scale
Standard Deviation 29.264
|
—
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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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—
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—
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Mean Change From Baseline for European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) - Arm B Expansion
Cycle 16 Day 1
|
NA Score on a scale
Standard Deviation NA
Summary statistics are not presented if fewer than 2 participants had reportable parameter values.
|
-8.33 Score on a scale
Standard Deviation 22.049
|
—
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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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—
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—
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—
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—
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—
|
Adverse Events
Arm A1: 90 mg PF-05212384 + Docetaxel
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Arm A2: 110 mg PF-05212384 + Docetaxel
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Arm A3: 130 mg PF-05212384 + Docetaxel
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A4: 150 mg PF-05212384 + Docetaxel
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Arm A5: 180 mg PF-05212384 + Docetaxel
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm B1: 90 mg PF-05212384 + Cisplatin
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm B2: 110 mg PF-05212384 + Cisplatin
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm B3: 130 mg PF-05212384 + Cisplatin
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Arm B4: 150 mg PF-05212384 + Cisplatin
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm B5: 180 mg PF-05212384 + Cisplatin
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Arm B6: 215 mg PF-05212384 + Cisplatin
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm B7: 260 mg PF-05212384 + Cisplatin
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Arm B8: 310 mg PF-05212384 + Cisplatin
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 1: 1L Metastatic
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 2: 2L/3L Metastatic
Serious events: 4 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 participants at risk
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 participants at risk
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 participants at risk
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 participants at risk
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 participants at risk
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 participants at risk
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib
n=15 participants at risk
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 participants at risk
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 participants at risk
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 participants at risk
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=3 participants at risk
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastatic
n=10 participants at risk
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
n=12 participants at risk
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Disease progression
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Vascular disorders
Deep vein thrombosis
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
Other adverse events
| Measure |
Arm A1: 90 mg PF-05212384 + Docetaxel
n=4 participants at risk
Participants with castrate resistant prostate cancer (CRPC), advanced breast cancer (ABC), or non-small cell lung cancer (NSCLC) that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A2: 110 mg PF-05212384 + Docetaxel
n=5 participants at risk
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A3: 130 mg PF-05212384 + Docetaxel
n=3 participants at risk
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A4: 150 mg PF-05212384 + Docetaxel
n=3 participants at risk
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm A5: 180 mg PF-05212384 + Docetaxel
n=5 participants at risk
Participants with CRPC, ABC, or NSCLC that were candidates to treatment with a docetaxel-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and docetaxel 75 mg/m2 1-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received docetaxel 75 mg/m2 1-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 505 days and the maximum duration of docetaxel treatment was 445 days.
|
Arm B1: 90 mg PF-05212384 + Cisplatin
n=4 participants at risk
Participants with urothelial transitional cell cancer (TCC), triple negative breast cancer (TNBC), NSCLC or ovarian cancer (OC) that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B2: 110 mg PF-05212384 + Cisplatin
n=3 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B3: 130 mg PF-05212384 + Cisplatin
n=3 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B4: 150 mg PF-05212384 + Cisplatin
n=3 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B5: 180 mg PF-05212384 + Cisplatin
n=3 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 180 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 180 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B6: 215 mg PF-05212384 + Cisplatin
n=10 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 215 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 215 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B7: 260 mg PF-05212384 + Cisplatin
n=5 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 260 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 260 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm B8: 310 mg PF-05212384 + Cisplatin
n=2 participants at risk
Participants with TCC, TNBC, NSCLC or OC that were candidates to treatment with a cisplatin-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 310 mg once on Day -7 and Cycle 1 Day 2, and cisplatin 75 mg/m2 2-hour IV infusion once on Cycle 1 Day 1. On Day 1 for Cycles 2 and beyond, participants received cisplatin 75 mg/m2 2-hour IV infusion once followed by PF-05212384 310 mg once. The maximum duration of PF-05212384 treatment was 414 days and the maximum duration of cisplatin treatment was 157 days.
|
Arm C1: 90 mg PF-052123 84 + 30 mg Dacomitinib
n=15 participants at risk
Participants with Her2+ breast cancer (BC) refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, head and neck squamous cell cancer (HNSCC), or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C1h: 90 mg PF-05212384 + 45 mg Dacomitinib
n=4 participants at risk
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 90 mg once on Day -14 and dacomitinib 45 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 45 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 45 mg orally once followed by PF-05212384 90 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C2: 110 mg PF-05212384 + 30 mg Dacomitinib
n=7 participants at risk
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 110 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 110 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C3: 130 mg PF-05212384 + 30 mg Dacomitinib
n=3 participants at risk
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 130 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 130 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm C4: 150 mg PF-05212384 + 30 mg Dacomitinib
n=3 participants at risk
Participants with BC refractory to prior herceptin or lapatinib, Her2+ esophago gastric cancer, HNSCC, or NSCLC that were candidates to treatment with a dacomitinib-based combination. Each treatment cycle was defined as 21 days. Participants received intravenous infusion of PF-05212384 150 mg once on Day -14 and dacomitinib 30 mg orally once on Day -7. On Cycle 1 Day 1, participants received dacomitinib 30 mg orally once. On Cycle 1 Day 2, participants received treatment with dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. On Day 1 for Cycles 2 and beyond, participants received dacomitinib 30 mg orally once followed by PF-05212384 150 mg once. The maximum duration of PF-05212384 treatment was 842 days and the maximum duration of dacomitinib treatment was 841 days.
|
Arm 1: 1L Metastatic
n=10 participants at risk
Participants with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
Arm 2: 2L/3L Metastatic
n=12 participants at risk
Participants with TNBC and one or two prior cytotoxic therapies in the metastatic setting received intravenous infusion of cisplatin 75 mg/m2 2-hour IV infusion followed by intravenous infusion of PF-05212384 180 mg. The maximum duration of PF-05212384 treatment was 728 days and the maximum duration of cisplatin treatment was 211 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Catheter site dermatitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Catheter site rash
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Infusion site pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Nail bed infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Blood creatine increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Body temperature increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Platelet count
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
6/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
30.0%
3/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
6/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Dystonia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
3/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Chalazion
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Faeces discoloured
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Faeces soft
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Haematochezia
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Cheilosis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Early satiety
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Tongue dry
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Chest pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Face oedema
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Feeling cold
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Axillary pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Malaise
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Pain
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Catheter site erythema
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Facial pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Oedema
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Puncture site pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Secretion discharge
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Swelling
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Catheter site irritation
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Ecthyma
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Eyelid folliculitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
3/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
3/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Localised infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Blood calcium increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Creatinine renal clearance abnormal
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Grip strength decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Human epidermal growth factor receptor decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Drooling
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Scab
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
28.6%
2/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
3/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Umbilical discharge
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Vascular disorders
Hypovolaemic shock
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Vascular disorders
Thrombophlebitis superficial
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Product Issues
Device dislocation
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Product Issues
Device occlusion
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Infusion site pruritus
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
70.0%
7/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
3/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
2/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
80.0%
8/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
91.7%
11/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
3/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
5/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
4/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
80.0%
4/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
5/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
5/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
5/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
6/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
3/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
75.0%
3/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
4/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
2/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
3/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
28.6%
2/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
90.0%
9/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
4/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
5/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
9/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
4/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
85.7%
6/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
41.7%
5/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
30.0%
3/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
30.0%
3/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Haemorrhoids
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
3/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
75.0%
3/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
90.0%
9/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
3/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
2/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
9/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
75.0%
3/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
57.1%
4/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
70.0%
7/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
75.0%
9/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
28.6%
2/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
41.7%
5/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
80.0%
8/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
2/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
6/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
4/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
6/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
8/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
3/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
5/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
2/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
28.6%
2/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
3/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Chills
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
5/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
3/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
9/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
57.1%
4/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
70.0%
7/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
75.0%
9/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Mucosal inflammation
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
3/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
80.0%
4/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
80.0%
8/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
3/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
2/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
80.0%
12/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
4/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
85.7%
6/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
6/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
58.3%
7/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
2/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
6/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
41.7%
5/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
5/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
42.9%
3/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
3/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
41.7%
5/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
30.0%
3/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
4/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
42.9%
3/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
4/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
4/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
41.7%
5/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
5/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
46.7%
7/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
28.6%
2/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
26.7%
4/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
75.0%
3/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
3/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
4/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
2/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
3/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
3/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
75.0%
3/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
30.0%
3/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
26.7%
4/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
30.0%
3/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
30.0%
3/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
5/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
4/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
3/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
4/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
3/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
53.3%
8/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
42.9%
3/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
5/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
3/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
60.0%
3/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
70.0%
7/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
2/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
100.0%
2/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
5/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
14.3%
1/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
41.7%
5/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
13.3%
2/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
57.1%
4/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
16.7%
2/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
66.7%
2/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Ear and labyrinth disorders
Ototoxicity
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
2/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
40.0%
4/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
2/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Blindness
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Keratitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Photopsia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
50.0%
1/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
3/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Gingival recession
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
25.0%
1/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
33.3%
1/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
6.7%
1/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
8.3%
1/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
10.0%
1/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
20.0%
1/5 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/2 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/15 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/4 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/7 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/3 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/10 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
0.00%
0/12 • Baseline up to 28 days after the last treatment administration or until all drug related toxicities have resolved, whichever is later. Maximum duration between first and last dose: 842 days.
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.
|
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